MAUDE Adverse Event Report: LABORIE MEDICAL TECHNOLOGIES AIR-CHARGED SINGLE SENSOR COUDÉ CATHETER; DEVICE, CYSTOMETRIC, HYDRAULIC

Model Number CAT878

Device Problems Material Protrusion/Extrusion (2979); Scratched Material (3020)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/31/2022

Event Type  malfunction  

Event Description

Air charged single sensor coude catheter inserted into patients penis for urodynamic assessment.Blood from penis noted by the r.N.Performing the procedure after insertion.The patient was not bleeding prior to the insertion of device.The r.N.Was concerned upon seeing the bleeding and proceeded to withdrawal the catheter.The r.N.Then observed a sharp, exposed curved wire protruding from the end of the catheter.The r.N.Then notified the m.D., charge r.N., and nurse manager.Assessment by clinical staff was small bleeding from penis.Patient was informed to monitor for worsening bleeding, increase fluids, and call the urology for worsening symptoms.

• Brand Name: AIR-CHARGED SINGLE SENSOR COUDÉ CATHETER
• Type of Device: DEVICE, CYSTOMETRIC, HYDRAULIC
• Manufacturer (Section D): LABORIE MEDICAL TECHNOLOGIES; 180 international drive; portsmouth NH 03801
• MDR Report Key: 14266036
• MDR Text Key: 295131942
• Report Number: 14266036
• Device Sequence Number: 1
• Product Code: FEN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CAT878
• Device Catalogue Number: TDOC-7FSC
• Device Lot Number: 214475
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/20/2022
• Event Location: Hospital
• Date Report to Manufacturer: 05/03/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 22265 DA
• Patient Sex: Male