MAUDE Adverse Event Report: LABORIE MEDICAL TECHNOLOGIES; DEVICE, CYSTOMETRIC, HYDRAULIC

Model Number CAT, TDOC, 1X SENS., COU. TIP, 7 FR 7FSC

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Abrasion (1689); Hemorrhage/Bleeding (1888)

Event Date 03/01/2022

Event Type  malfunction  

Event Description

The event involved a tdoc catheter, model number cat878, used for a urodynamic study.During the study the patient notified the provider that the catheter was uncomfortable, and the catheter was removed.The patient experienced bleeding which was controlled with gauze and pressure application.Upon examination of the catheter used, the sensor wire within the catheter had dislodged from the end of the catheter likely causing an abrasion of the ureteral mucosa.The patient has urinary retention requiring intermittent catherization and an indwelling catheter had to be placed at the time to avoid further irritation of likely abrasion caused by the catheter.This incident did not result in a serious injury of the patient.The event is being reported as if this incident was to occur again may require medical intervention to prevent serious injury of the patient.

• Type of Device: DEVICE, CYSTOMETRIC, HYDRAULIC
• Manufacturer (Section D): LABORIE MEDICAL TECHNOLOGIES; 180 international drive; portsmouth NH 03801
• Manufacturer (Section G): CLINICAL INNOVATIONS LLC; 747 w 4170 st; murray UT 84123
• Manufacturer Contact: chanrasmey white ; 180 international drive; portsmouth, NH 03801 ; 6032881744
• MDR Report Key: 13968999
• MDR Text Key: 298200034
• Report Number: 3017448360-2022-00010
• Device Sequence Number: 1
• Product Code: FEN
• Combination Product (y/n): N
• PMA/PMN Number: K951805
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 06/16/2023
• Device Model Number: CAT, TDOC, 1X SENS., COU. TIP, 7 FR 7FSC
• Device Catalogue Number: CAT878
• Device Lot Number: 214195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2022
• Distributor Facility Aware Date: 03/01/2022
• Date Manufacturer Received: 03/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1