MAUDE Adverse Event Report: LABORIE MEDICAL TECHNOLOGIES CANADA ULC T-DOC AIR-CHARGED SINGLE SENSOR COUDE CATHETER; CATHETER FOR USE WITH URODYNAMIC SYSTEMS

Model Number CAT878

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem No Code Available (3191)

Event Date 05/15/2019

Event Type  malfunction  

Manufacturer Narrative

This incident did not result in a serious injury of the patient or require medical intervention; however, this event is being reported to the fda based on a review of the risk documentation for the device which identified that, were this malfunction to occur again, there is the possibility that medical intervention might be necessary to prevent serious injury.Laborie is still awaiting additional information from the reporter related to this event, as well as the subject device to be returned, in order for a more thorough investigation to be performed.Once laborie has obtained further details on this event and has been able to review potential root causes, a follow-up report will be submitted to fda.

Event Description

A laborie urethral catheter was used in a patient in france as part of a urodynamics study.A metal filament in the catheter was protruding and resulted in a lesion of the patient's urethra.

• Brand Name: T-DOC AIR-CHARGED SINGLE SENSOR COUDE CATHETER
• Type of Device: CATHETER FOR USE WITH URODYNAMIC SYSTEMS
• Manufacturer (Section D): LABORIE MEDICAL TECHNOLOGIES CANADA ULC; 6415 northwest dr; unit 10; mississauga, L4V1X 1; CA L4V1X1
• Manufacturer (Section G): CLINICAL INNOVATIONS LLC; 747 w 4170 st; murray UT 84123
• Manufacturer Contact: nicole boser ; 6415 northwest drive; unit 10; mississauga, ontario L4V1X-1 ; CA L4V1X1
• MDR Report Key: 8695411
• MDR Text Key: 201859184
• Report Number: 9681424-2019-00002
• Device Sequence Number: 1
• Product Code: FEN
• UDI-Device Identifier: 00627825001045
• UDI-Public: 00627825001045
• Combination Product (y/n): N
• PMA/PMN Number: K951805
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/13/2019

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: 11/16/2020
• Device Model Number: CAT878
• Device Catalogue Number: TDOC-7FSC
• Device Lot Number: 181576
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/13/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/16/2018
• 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