MAUDE Adverse Event Report: TELEFLEX MEDICAL OEM UROPASS AS 12/14FR X 38 CM 5/BX; ACCESSORIES, CATHETER, G-U

Model Number 61238BX

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to olympus for evaluation.The cause of the reported complaint cannot be confirmed.To prevent device breakage and injury to the patient, the device instructions for use document 08021 rev.Be warns ¿do not insert this device if it has been kinked or damaged prior to use ¿ replace with undamaged product¿.Also, ¿avoid contact with sharp objects as the device can be easily nicked¿.The document also warns not to advance the device if resistance is felt or the dilator is missing.The placement of the dilator/sheath assembly must also be confirmed via fluoroscopy.The instructions for use document also has pre-procedure inspection instructions: ¿inspect the device for any evidence of kinks, nicks, tears, or cracks that might have occurred in the delivery of the device to the sterile field.¿.

Event Description

Olympus was informed that towards the end of an unknown procedure, an approximately 2 centimeter fragment from the tip of the device broke off in the patient as the device was being removed from the patient.The broken off tip was successfully removed from the patient using a semi-rigid wolf 3fr flexible grasper.There was no reported patient injury.

Manufacturer Narrative

The oem performed further investigations.A review of the dhr did not reveal any non-conformances or in process deviations that could have contributed to the issues the customer is experiencing.Product met all form, fit and functional requirements.No device was returned, however, pictures received showed the dilator tip and shaft broken into multiple pieces.The exact cause of the reported event could not be confirmed.However, based on similar reported complaints the potentially cause of the broken tip can be attributed to user handling (unintended) or degradation due to environmental conditions.

• Brand Name: UROPASS AS 12/14FR X 38 CM 5/BX
• Type of Device: ACCESSORIES, CATHETER, G-U
• Manufacturer (Section D): TELEFLEX MEDICAL OEM; 3750 annapolis lane north, suite 160; plymouth MN 55447
• MDR Report Key: 8276710
• MDR Text Key: 135371973
• Report Number: 2951238-2019-00392
• Device Sequence Number: 1
• Product Code: KNY
• 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: 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 61238BX
• Device Lot Number: 09G1400007
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1