MAUDE Adverse Event Report: LABORIE MEDICAL TECHNOLOGIES CANADA ULC TDOC-7FS AIR-CHARGED SINGLE SENSOR CATHETER; DEVICE, CYSTOMETRIC, HYDRAULIC

Model Number CAT895

Device Problem Inflation Problem (1310)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/29/2022

Event Type  malfunction  

Event Description

The balloon failed to inflate during the procedure.

• Brand Name: TDOC-7FS AIR-CHARGED SINGLE SENSOR CATHETER
• Type of Device: DEVICE, CYSTOMETRIC, HYDRAULIC
• Manufacturer (Section D): LABORIE MEDICAL TECHNOLOGIES CANADA ULC; 180 international drive; portsmouth NH 03801
• MDR Report Key: 16434945
• MDR Text Key: 310146082
• Report Number: 16434945
• 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: 02/14/2023

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: CAT895
• Device Lot Number: 221808
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/14/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/24/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/24/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1