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Brief Summary Document - HCP
Product
Percutaneous Access Set with Catheter - IFU number 51554742
Rx Statement
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a licensed practitioner.
Prior to use, please refer to all applicable “Instructions for Use” for more information on Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential Adverse Events, and Operator’s Instructions.
Intended Use/Indications for Use
The Percutaneous Access Set is intended to establish percutaneous nephrostomy access and is indicated for drainage of urine and antegrade pyelography.
Contraindications
The Percutaneous Access Set is contraindicated for:
- Use in patients with blood clotting anomalies due to coagulopathies or pharmacological anticoagulations.
- Where percutaneous drainage catheterization is unacceptable.
Warnings
Reuse Warning
Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found, call your Boston Scientific representative.
For single use only. Do not reuse, reprocess, or resterilize. Reuse, reprocessing, or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness, or death. Reuse, reprocessing, or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness, or death of the patient.
General Warnings
- Do not bend or kink the catheter during, prior to, or after placement (including external fixation). Doing so could damage the integrity of the catheter and result in catheter encrustation and occlusion, inadequate drainage and patient injury.
- Catheters are not intended to be permanent implant devices. The indwelling time for the catheter should not exceed 90 days. An indwell time of more than 90 days may result in encrustation/ occlusion and patient injury. This catheter should be evaluated by the physician periodically to assess patency and function.
Precautions
- If resistance is encountered during advancement or withdrawal of the access components or catheter, STOP. Do not continue without first determining the cause of the resistance and taking remedial action. Failure to do so may result in damage to the device, patient injury and/or additional interventions.
- While placing the catheter into the appropriate area of the collecting system, advance the catheter over the guidewire until the distal tip enters the renal pelvis. Advance the catheter into the appropriate area of the collecting system. Inability to advance the catheter into the nephrostomy tract and appropriate area of the collecting system may result in a prolonged procedure and/or patient injury.
- Ensure the catheter pigtail is formed and confirm positioning. Failure to do so may lead to catheter migration/ dislodgement, catheter damage and/or patient injury.
- Upon procedure completion, ensure the catheter is secured and an appropriate drainage tube is connected. Failure to do so may result in catheter migration/ dislodgement, inadequate urine drainage, additional intervention and/or patient injury.
- Pregnant patients require more frequent examinations for catheter patency and function and may require subsequent catheter exchange.
- Do not use excessive force to detach the syringe from the catheter hub after contrast injection. Use of excessive force to detach the syringe may result in catheter migration.
Potential adverse events
Complications include, but are not limited to:
- Catheter dislodgement
- Catheter occlusion
- Colon injury
- Discomfort / pain
- Edema
- Encrustation
- Extravasation
- Fistula
- Hematoma
- Hemorrhage
- Hydronephrosis
- Infection
- Inflammation
- Loss of renal function
- Perforation
- Pneumothorax
- Tissue damage