MAUDE Adverse Event Report: LABORIE MEDICAL TECHNOLOGIES CANADA ULC T-DOC; 7FR DUAL SENSOR CATHETER

Model Number T-DOC-7FD

Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 11/13/2014

Event Type  malfunction  

Event Description

During urodynamic diagnostic procedure, then the urodynamic catheter was withdrawn from the patient's bladder, the sensor was missing.

Manufacturer Narrative

The initial report from (b)(6) competent authority for medical devices was in (b)(4) language, difficult to understand and provided limited information.Once we received back the catheter on february 19, 2015 we were able to determine this ins a reportable event.The urodynamic catheter returned is missing 8 centimeters (3.15 inches) or length from the urethral pressure sensor balloon to the distal tip of the catheter.Will follow up with customer to determine if a rigid scope and/or any surgical device or instrument was used at any time during the urodynamic procedure, including during catheter insertion and catheter withdrawal.This to ensure the catheter was not damaged by other means at the customer's location.

• Brand Name: T-DOC
• Type of Device: 7FR DUAL SENSOR CATHETER
• Manufacturer (Section D): LABORIE MEDICAL TECHNOLOGIES CANADA ULC; 6415 northwest dr.; unit 11; mississauga L4V1X 1; CA L4V1X1
• Manufacturer (Section G): CLINICAL INNOVATIONS; 747 w 4170 s; murray UT
• Manufacturer Contact: gerald loney ; 6415 northwest dr.; unit 10; mississauga L4V1X-1 ; CA L4V1X1 ; 6121170
• MDR Report Key: 4645901
• MDR Text Key: 5682092
• Report Number: 9681424-2015-00001
• Device Sequence Number: 1
• Product Code: FEN
• Combination Product (y/n): N
• Reporter Country Code: RE
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 02/26/2015

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: 08/22/2015
• Device Model Number: T-DOC-7FD
• Device Catalogue Number: CAT880
• Device Lot Number: 130912
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/30/2014
• Initial Date FDA Received: 02/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 75