FDA Adverse Event
Malfunction
Summary report: N
COOL PATH DUO 7F, 1304-CP2-7-1.5(5)-L-TE4BE1AB
MDR report key: 2093857
·
Received April 6, 2011
Report
- Report Number
- 2030404-2011-00092
- Event Type
- Malfunction
- Date Received
- April 6, 2011
- Date of Event
- March 9, 2011
- Report Date
- March 9, 2011
- Manufacturer
- ST JUDE MEDICAL, IRVINE
- Product Code
- OAD
- PMA / PMN Number
- P060019
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). WE ARE AWAITING DEVICE RETURN. IF THE DEVICE IS RETURNED FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED WITH THE RESULTS OF OUR INVESTIGATION.
Description of Event or Problem · 1
IT WAS REPORTED WHILE PERFORMING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, THE IRRIGATION PORT BROKE FROM THE HANDLE. THERE WERE NO CONSEQUENCES TO THE PATIENT. PATIENT STATUS POST-PROCEDURE WAS LISTED AS GOOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COOL PATH DUO 7F, 1304-CP2-7-1.5(5)-L-TE4BE1AB | CARDIAC ABLATION CATHETER | OAD | ST JUDE MEDICAL, IRVINE | 83563 | 3285198 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR |