MAUDE Adverse Event Report: COOK INC ULTRAXX NEPHROSTOMY BALLOON; LJE CATHETER, NEPHROSTOMY

Catalog Number UNB-8-15

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/25/2021

Event Type  malfunction  

Manufacturer Narrative

This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

As reported, during a percutaneous nephrolithotomy, an ultraxx nephrostomy balloon ruptured when inflating with water to approximately 15atm for ten seconds.A new device of the same product reference number was used to complete the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional intervention due to this occurrence.The patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Event summary: cook was informed of an incident involving an ultraxx nephrostomy balloon from an unknown production lot.As reported, the operator inflated water into the balloon around 15atm, but the balloon broke after 10 seconds.The procedure was completed using another new device.No adverse events were reported.Investigation ¿ evaluation.A visual inspection and functional testing of the returned device was conducted.A document-based investigation was also performed including a review of drawing, the instructions for use, manufacturing instructions, and quality control data.The complainant returned one package containing a ultraxx nephrostomy balloon for investigation.Part number: unb-8-15, lot number: unknown, manufacture date: unknown, expiration date: unknown.The catheter was received with the balloon inflated with liquid.A function test was performed by injecting the balloon with water using a syringe.The balloon was able to be inflated and deflated.No leaks were observed in the device.Cook could not complete a review of the device history record (dhr) due to lack of lot information from the user facility.Cook could not complete a trackwise search of other complaints associated with the complaint device lot number due to lack of lot information from the user facility.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: warnings: always inflate the balloon with a sterile liquid.Never inflate with air, carbon dioxide, or any other gas.Do not overinflate.Using excessive pressure to inflate the balloon on this device can cause the balloon to rupture.Precautions- ultraxx nephrostomy balloon and set: do not exceed the maximum rated burst pressure (listed on label) for this balloon device.Do not preinflate the balloon.Refer to product label or the inflation check valve on the balloon device for appropriate balloon volume potential adverse events: complications that might occur during this procedure include over inflation of the balloon, which could result in trauma to the surrounding tissue.The complaint was not able to be confirmed, as the returned device functioned properly during laboratory testing.Per the quality engineering risk assessment, no further action is warranted.Cook medical will continue to monitor this device via the complaints database for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No new patient or event information since the last report was submitted.

• Brand Name: ULTRAXX NEPHROSTOMY BALLOON
• Type of Device: LJE CATHETER, NEPHROSTOMY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11266815
• MDR Text Key: 254169446
• Report Number: 1820334-2021-00232
• Device Sequence Number: 1
• Product Code: LJE
• Combination Product (y/n): N
• PMA/PMN Number: K024050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNB-8-15
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2021
• Initial Date Manufacturer Received: 01/26/2021
• Initial Date FDA Received: 02/02/2021
• Supplement Dates Manufacturer Received: 03/16/2021
• Supplement Dates FDA Received: 03/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1