MAUDE Adverse Event Report: TELEFLEX MEDICAL OEM UROPASS AS 11/13FR X 46 CM 5/BX

Model Number 61146BX

Device Problem Split (2537)

Patient Problem No Code Available (3191)

Event Date 06/21/2017

Event Type  malfunction  

Manufacturer Narrative

At the time of this report, the device has not yet been returned for evaluation.As a result, a determination cannot be made at this time.If further information becomes available, gyrus acmi will continue the investigation and update the agency accordingly.

Event Description

Ureteral access sheath was being inserted into right ureter by surgeon and it was noted that the end of catheter was split.A second ureteral sheath was used only to find that it split at the same point.Third ureteral sheath was used with same result.Device 3 of 3.Please see related complaint - (b)(4).

Manufacturer Narrative

This supplemental report is being submitted to provide device evaluation results from the original equipment manufacturer (oem), based on the picture.Please see the updates in sections: g4, g7, h2, h6 and h10.Based on the picture investigation, oem feels the root cause is substantial light exposure of the devices in the heal care facilities which resulted in degradation and embrittlement of the dilator polymer.This failure mode is not within oem's control.Product met the product specifications at time of manufacture.Since oem was not responsible for design validation, accelerated aging and storage/environmental evaluation of the device post sterilization, oem is unable to confirm the complaints.Current dilator inventory was sampled and checked for flexibility and brittleness through completion of a bend test.All product inventory passed inspection and was released.Although complaint is not confirmed, oem will implement a preventive action ecn in which the minimum elongation and tensile break will be increased.This will provide additional initial polymer material strength on extruded dilator tubing material and would offer surplus tubing flexibility.As such, this could reduce or eliminate early product failures due to environmental storage conditions, specifically light exposure.

• Brand Name: UROPASS AS 11/13FR X 46 CM 5/BX
• Manufacturer (Section D): TELEFLEX MEDICAL OEM; 3750 annapolis lane north, suite 160; plymouth MN 55447
• MDR Report Key: 7193559
• MDR Text Key: 97954226
• Report Number: 3005975494-2018-00002
• Device Sequence Number: 1
• Product Code: KNY
• Combination Product (y/n): N
• PMA/PMN Number: PK051593
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 61146BX
• Device Lot Number: 09E1600089
• Other Device ID Number: UDI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention