MAUDE Adverse Event Report: TELEFLEX MEDICAL OEM UROPASS AS 10/12FR X 24 CM 5/BX; URETERAL ACCESS SHEATH

Model Number 61024BX

Device Problems Break (1069); Flaked (1246)

Patient Problem No Patient Involvement (2645)

Event Date 12/03/2019

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the service center for evaluation of the reported event.Therefore, the exact cause of the event cannot be determined at this time.If the device becomes available, an evaluation report will be submitted.

Event Description

The service center received a report, medwatch (mw5091479) received on december 20, 2019, that an access sheath failed out of the box during preparation for a procedure.The uropass sheath (61024bx) was passed to the back table to a fellow and wetted prior to insertion for a cystoscopy and ureteroscopy procedure.During the preparation and inspection, the fellow observed the sheath began to chip and the tip of the sheath (61024bx) fell off.The tip and the chipped items were removed from the back table and placed back into the original packaging.It was reported the item was not expired.It was not reported if the intended procedure was continued with a new device or completed.

Manufacturer Narrative

This supplemental report is being submitted to provide the initial device evaluation, additional information supplied by the original equipment manufacturer (oem)and correction to the event date.Please see updated sections: b3, b4, d4,d10,g4, g7, h2, h3, h4, h6, and h10.Udi#(b)(4).The uropass ureteral access sheath (model 61024bx), lot number 09a1700256, was received at the service center for evaluation of the sheath began to chip and the tip of the sheath fell off before use in a patient.The user¿s complaint was confirmed.The returned condition device, 61024bx, was received in a poly bag with the original tyvek packaging included.The lot number was confirmed to be 09a1700256 and the device appeared to be unused.Visual inspection of the device observed that the distal tip broken off and small pieces of the tip located in the original package.The broken distal tip was measured to be approximately 6.5 cm in length.Additionally, the cone was observed to have a crack in the weld area.The crack was measured to be approximately 1.0 cm in length.The root cause for the broken distal tip and cracked cone was unable to be determined.The device was forwarded to the original equipment manufacturer for further investigation.The original equipment manufacturer (oem) performed a device history record review on the manufactured lot 09a1700256 and noted there were no non-conformances in the processing of the device.The product passed all finished release inspections.The oem has implemented the necessary steps to address the reported issue and will continue to monitor this failure mode.

• Brand Name: UROPASS AS 10/12FR X 24 CM 5/BX
• Type of Device: URETERAL ACCESS SHEATH
• Manufacturer (Section D): TELEFLEX MEDICAL OEM; 3750 annapolis lane north, suite 160; plymouth MN 55447
• MDR Report Key: 9521555
• MDR Text Key: 177765065
• Report Number: 2951238-2019-01235
• Device Sequence Number: 1
• Product Code: FGF
• Combination Product (y/n): N
• PMA/PMN Number: K051593
• 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: 03/13/2020

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 Expiration Date: 01/24/2022
• Device Model Number: 61024BX
• Device Lot Number: 09A1700256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/05/2019
• Initial Date FDA Received: 12/26/2019
• Supplement Dates Manufacturer Received: 02/18/2020
• Supplement Dates FDA Received: 03/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1