FDA Adverse Event
Malfunction
Summary report: N
THERAPY¿ COOL PATH¿ DUO ABLATION CATHETER
MDR report key: 12751318
·
Received November 4, 2021
Report
- Report Number
- 2030404-2021-00081
- Event Type
- Malfunction
- Date Received
- November 4, 2021
- Date of Event
- October 26, 2021
- Report Date
- February 1, 2022
- Manufacturer
- ST. JUDE MEDICAL, INC.
- Product Code
- OAD
- PMA / PMN Number
- P110016
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ONE QUADRIPOLAR, THERAPY COOL PATH DUO IRRIGATED ABLATION CATHETER WAS RECEIVED FOR EVALUATION. THE CATHETER CREATED AN ¿S¿ SHAPED CURVE DURING DEFLECTION, WHICH NO LONGER MATCHED THE REQUIRED CURVE TEMPLATE. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. THE CAUSE FOR THE REPORTED DEFLECTION ISSUE AND SUBSEQUENT DELAY WAS DUE TO AN ¿S¿ SHAPED CURVE WHERE THE ACTIVATION WIRE SHIFTED OVER THE FLAT WIRE.
Description of Event or Problem · 1
RELATED MANUFACTURING REF: 2030404-2021-00082. DURING A SUPRAVENTRICULAR TACHYCARDIA ABLATION PROCEDURE, THE CATHETER DID NOT DEFLECT AS INTENDED WHICH CAUSED A DELAY. ANOTHER CATHETER WAS USED TO COMPLETE THE PROCEDURE WITH NO CONSEQUENCES TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1651493 | THERAPY¿ COOL PATH¿ DUO ABLATION CATHETER | CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER | OAD | ST. JUDE MEDICAL, INC. | IBI-83562 | 7733186 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | THERAPY¿ COOL PATH¿ ABLATION CATH| THERAPY¿ COOL PATH¿ ABLATION CATH |