MAUDE Adverse Event Report: ST. JUDE MEDICAL JOSEPHSON CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Lot Number 3990743

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 06/24/2020

Event Type  malfunction  

Event Description

The catheter in use had been reprocessed and was unable to perform properly.

• Brand Name: JOSEPHSON CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL; 2305 walnut street; roseville MN 55113
• MDR Report Key: 16852757
• MDR Text Key: 314390989
• Report Number: 16852757
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/19/2023,06/25/2020

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 Lot Number: 3990743
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/19/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/02/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/02/2023
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28470 DA
• Patient Sex: Female