MAUDE Adverse Event Report: LABORIE MEDICAL TECHNOLOGIES CANADA ULC TDOC AIR-CHARGED CATHETER; CATHETER FOR USE WITH URODYNAMIC SYSTEM

Model Number	CAT 880
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	02/11/2019
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.
Event or Problem Description
A laborie catheter which was used in a male patient in (b)(6) as part of a urodynamics study had a steel wire protruding from the catheter.The physician either did not notice the defect prior to inserting the catheter into the patient, or the defect occurred after insertion into the patient - we are unable to tell based on the information provided - which resulted in the patient's urethra receiving minor scratches upon removal of the catheter.No medical intervention was required as a result of this product malfunction; the patient was released and did not require additional follow-up or treatments.

• Brand Name: TDOC AIR-CHARGED CATHETER
• Common Device Name: CATHETER FOR USE WITH URODYNAMIC SYSTEM
• Manufacturer (Section D): LABORIE MEDICAL TECHNOLOGIES CANADA ULC; 6415 northwest dr; unit 10; mississauga, ontario L4V1X 1; CA L4V1X1
• MDR Report Key: 8427288
• Report Number: 9681424-2019-00001
• Device Sequence Number: 13898401
• Product Code: FEN
• UDI-Device Identifier: 00627825001045
• UDI-Public: 00627825001045
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K951805
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 03/12/2019

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 Model Number: CAT 880
• Device Lot Number: 180716
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/11/2019
• Initial Report FDA Received Date: 03/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1