MAUDE Adverse Event Report: TELEFLEX MEDICAL OEM UROPASS AS 10/12FR X 54 CM 5/BX

Model Number 61054BX

Device Problem Break (1069)

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

Event Date 12/05/2019

Event Type  malfunction  

Manufacturer Narrative

The access sheath was not returned to service center for evaluation.The cause of the reported event cannot be determined.The instruction manual states ¿ avoid contact with sharp objects as the device can be easily nicked, thereby increasing the potential for breakage.¿.

Event Description

The service center was informed that during an unspecified procedure, the tip of the ureteral access sheath broke off and fell inside the patient.This caused the doctor to spend a couple of hours more in the case to retrieve the broken piece.It is unknown if the intended procedure was completed.There was no patient injury reported.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information received.Additional information obtain in the medwatch states the intended procedure was a cystoscopy, ureteroscopy with stent exchange and laser lithotripsy.The sheath was being utilized appropriately by the attending surgeon prior to breakage.Additional time was used to perform a more thorough urteroscopy and cystoscopy to confirm that pieces of the access sheath have been removed.Per the attending surgeon, the patient was scheduled for a ct scan and follow-up.During the cystoscopy the access sheath was inserted without resistance.The procedure continued on to complete the stent exchange and the laser lithotripsy.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information received from the original equipment manufacturer (oem) teleflex.The oem performed a review of the dhr for 500038-30 batch 09m170013 complaint was shipped on 07-dec-2017 with a lot quantity of 20 five packs (100 units).The product was manufactured using dilator lot t5637-04 batch 08a1500533 and 08c1500553.The lot passed all inspection criteria.The oem reported that the bend test was not added to specification until november 2014; batch produced prior to november 2014 which would cover batch 08c1500553.The oem reported that the root cause was environmentally related exposure of the device in the health care facilities which resulted in degradation and embrittlement of the dilator polymer, teleflex believes there is no manufacturing, material, or process related cause for this failure mode that would be considered within telefelx¿s control.Since teleflex is not responsible for design validation, accelerated aging, and storage/environmental evaluation of the device post sterilization.Teleflex is unable to confirm the complaint.

• Brand Name: UROPASS AS 10/12FR X 54 CM 5/BX
• Type of Device: UROPASS AS 10/12FR X 54
• Manufacturer (Section D): TELEFLEX MEDICAL OEM; 3750 annapolis lane north, suite 160; plymouth MN 55447
• MDR Report Key: 9539765
• MDR Text Key: 199255018
• Report Number: 2951238-2020-00294
• Device Sequence Number: 1
• Product Code: KNH
• 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,other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/06/2020

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 Model Number: 61054BX
• Device Lot Number: 09M1700013
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/05/2019
• Initial Date FDA Received: 01/02/2020
• Supplement Dates Manufacturer Received: 02/04/2020; 03/10/2020
• Supplement Dates FDA Received: 02/27/2020; 04/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 17 YR