FDA Adverse Event
Malfunction
Summary report: N
TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿ BID CURVE D-F
MDR report key: 16992075
·
Received May 24, 2023
Report
- Report Number
- 3008452825-2023-00214
- Event Type
- Malfunction
- Date Received
- May 24, 2023
- Date of Event
- May 18, 2023
- Report Date
- August 8, 2023
- Manufacturer
- ST. JUDE MEDICAL
- Product Code
- OAE
- UDI-DI
- 05415067027641
- PMA / PMN Number
- P130026
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PO
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
IT WAS REPORTED THAT THE TACTICATH WAS EXPIRED AT THE TIME OF USE. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, TACTICATH SE BATCH NUMBER 8012218 EXPIRED ON NOVEMBER 30, 2022 WHICH WAS PRIOR TO THE REPORTED EVENT DATE OF MAY 18, 2023. A REVIEW OF DISTRIBUTION RECORDS CONFIRMED THAT THIS PRODUCT WAS DISTRIBUTED PRIOR TO ITS EXPIRATION DATE. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED, INCLUDING VERIFICATION OF THE EXPIRATION DATE LISTED ON THE PRODUCT LABEL. THE CAUSE OF THE USE OF EXPIRED PRODUCT IS CONSISTENT WITH USER ERROR.
Description of Event or Problem · 0
DURING A VENTRICULAR TACHYCARDIA ABLATION PROCEDURE, AN EXPIRED ABLATION CATHETER WAS USED WITH NO CONSEQUENCES TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 948154 | TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿ BID CURVE D-F | CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION | OAE | ST. JUDE MEDICAL | A-TCSE-DF | 8012218 | 05415067027641 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |