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
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/15/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: CATHETER FOR USE WITH URODYNAMIC SYSTEMS
• Manufacturer (Section D): LABORIE MEDICAL TECHNOLOGIES CANADA ULC; 6415 northwest dr; unit 10; mississauga, L4V1X 1; CA L4V1X1
• MDR Report Key: 8695411
• Report Number: 9681424-2019-00002
• Device Sequence Number: 13925366
• Product Code: FEN
• UDI-Device Identifier: 00627825001045
• UDI-Public: 00627825001045
• Combination Product (Y/N): N
• PMA/510(K) Number: K951805
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 11/16/2020
• Device Model Number: CAT878
• Device Catalogue Number: TDOC-7FSC
• Device Lot Number: 181576
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1