FDA Adverse Event
Malfunction
Summary report: N
COOL PATH DUO 7F, 1304-CP2-7-1.5(5)-L-TE4BE1AB
MDR report key: 2121791
·
Received May 20, 2011
Report
- Report Number
- 2030404-2011-00143
- Event Type
- Malfunction
- Date Received
- May 20, 2011
- Date of Event
- April 5, 2011
- Report Date
- May 2, 2011
- Manufacturer
- ST. JUDE MEDICAL, IRVINE
- Product Code
- OAD
- PMA / PMN Number
- P060019
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- 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.
Description of Event or Problem · 1
IT WAS REPORTED DURING AN ABLATION PROCEDURE, THE IRRIGATION PORT BROKE FROM THE HANDLE OF THE CATHETER AND THERE WAS AN OCCLUSION ALARM. THERE WERE NO CONSEQUENCES TO THE PATIENT. PATIENT STATUS WAS LISTED AS STABLE. ADDITIONAL INFORMATION WAS REQUESTED, BUT IS NOT AVAILABLE.
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 PERCUTANEOUS CATHETER | OAD | ST. JUDE MEDICAL, IRVINE | 83563 | 3275224 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |