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

Model Number CAT 880

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem Tissue Damage (2104)

Event Date 02/11/2019

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.

Event 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
• Type of Device: 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
• Manufacturer (Section G): CLINICAL INNOVATIONS LLC; 747 w 4170 s; murray UT 84123
• Manufacturer Contact: nicole boser ; 6415 northwest drive; unit 10; mississauga, ontario L4V1X-1 ; CA L4V1X1
• MDR Report Key: 8427288
• MDR Text Key: 139186684
• Report Number: 9681424-2019-00001
• Device Sequence Number: 1
• Product Code: FEN
• UDI-Device Identifier: 00627825001045
• UDI-Public: 00627825001045
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K951805
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/11/2019
• Initial Date FDA Received: 03/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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