FDA Adverse Event
Malfunction
Summary report: N
COOL PATH DUO 7F, 1304-CP2-7-1.5(5)-L-TE4BE1AB
MDR report key: 2081171
·
Received April 14, 2011
Report
- Report Number
- 2030404-2011-00097
- Event Type
- Malfunction
- Date Received
- April 14, 2011
- Date of Event
- March 15, 2011
- Report Date
- March 16, 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.
Description of Event or Problem · 1
IT WAS REPORTED WHILE USING THE CATHETER FOR AN ABLATION PROCEDURE, THE IRRIGATION TUBING BROKE FROM THE HANDLE END OF THE CATHETER. THERE WERE NO CONSEQUENCES TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COOL PATH DUO 7F, 1304-CP2-7-1.5(5)-L-TE4BE1AB | THERAPY COOL PATH ABLATION | OAD | ST. JUDE MEDICAL, IRVINE | 83563 | 3285198 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR |