MAUDE Adverse Event Report: TELEFLEX MEDICAL OEM UROPASS AS 13/15FR X 46 CM 5/BX

Model Number 61346BX

Device Problems Break (1069); Split (2537)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/05/2018

Event Type  malfunction  

Manufacturer Narrative

The device was discarded by the user facility and will not be returned to olympus for evaluation.The cause of the reported event could not be determined.If further information becomes available, gyrus acmi will continue the investigation and update the agency accordingly.Device was discarded.

Event Description

Uropass broken in patient.Customer had an issue when inserting the sheath over a guidewire into the ureter.When the middle section of the sheath was removed it was noted that the white tapered tip was split.The user was a registrar but they do use the product regularly.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information based on the dhr review performed.Based on the dhr review the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.

Manufacturer Narrative

The report's conclusion was that the root cause is environmental related exposure of the device which resulted in degradation and embrittlement of the dilator polymer.The failure mode cause is not considered within teleflex's control.Since teleflex was not responsible for the design validation, accelerated aging and storage/environmental evaluation of the device post sterilization, teleflex is unable to confirm the cause of the complaint.

• Brand Name: UROPASS AS 13/15FR X 46 CM 5/BX
• Type of Device: UROPASS
• Manufacturer (Section D): TELEFLEX MEDICAL OEM; 3750 annapolis lane north, suite 160; plymouth MN 55447
• MDR Report Key: 7458863
• MDR Text Key: 107089109
• Report Number: 3005975494-2018-00006
• 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,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 04/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 61346BX
• Device Lot Number: 09M1500100
• Other Device ID Number: UDI
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1