MAUDE Adverse Event Report: TELEFLEX MEDICAL OEM UROPASS AS 12/14FR X 54 CM 5/BX; URETERAL ACCESS SHEATH

Model Number 61254BX

Device Problem Split (2537)

Patient Problem Blood Loss (2597)

Event Date 05/02/2016

Event Type  Injury  

Manufacturer Narrative

The device was not returned to olympus for evaluation.The cause of the patient's outcome cannot be conclusively determined.Olympus followed up with the user facility to obtain additional information regarding the reported events by telephone and in writing but with no result.The most likely cause for this reported event is excessive force being applied by the user during use or when encountering resistance.The instruction manual warns users: ¿advance the dilator/sheath assembly over the guidewire to the desired location.If resistance is encountered, stop! do not advance against resistance.Damage to the anatomy could result.¿.

Event Description

Olympus was informed that during a therapeutic ureteroscopy procedure, upon introduction the distal tip of the sheath split apart and the patient sustained internal bleeding.The bleeding was controlled with an unknown device.The intended procedure was completed.

Manufacturer Narrative

The device was not returned and no photo images were provided to olympus for evaluation.This device is manufactured by teleflex a third party vendor that cannot accept field devices and requires photos instead for the complaint investigation.The oem performed a dhr review and revealed that the product met specifications at the time of manufacturing.The oem reported that on october 31, 2014 a shipment of 200 5- pack devices was sent to olympus for distribution.The oem performed a complaint history review for the units provided and found 1 other complaint associated with this same lot number (tfx 500038-14 batch 09k1400180).Since the customer did not return the device or provide photo images no further investigation could be performed.The exact cause for the reported event could not be determined.

• Brand Name: UROPASS AS 12/14FR X 54 CM 5/BX
• Type of Device: URETERAL ACCESS SHEATH
• Manufacturer (Section D): TELEFLEX MEDICAL OEM; 3750 annapolis lane north, suite 160; plymouth 55447
• Manufacturer Contact: donny shapiro ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-516
• MDR Report Key: 5677146
• MDR Text Key: 45853486
• Report Number: 2951238-2016-00453
• Device Sequence Number: 1
• Product Code: KNY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK051593
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 61254BX
• Device Catalogue Number: 61254BX
• Device Lot Number: 09K1400180
• Other Device ID Number: UDI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/07/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention