FDA Adverse Event
Malfunction
Summary report: N
COOL PATH DUO 7F, 1304-CP2-7-1.5(5)-L1-TE4BE1AB
MDR report key: 2081153
·
Received April 14, 2011
Report
- Report Number
- 2030404-2011-00098
- Event Type
- Malfunction
- Date Received
- April 14, 2011
- Date of Event
- March 15, 2011
- Report Date
- March 18, 2011
- Manufacturer
- ST. JUDE MEDICAL, IRVINE
- Product Code
- OAD
- PMA / PMN Number
- P060019
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). WE ARE IN THE PROCESS OF EVALUATING THE DEVICE. WHEN THE ANALYSIS IS COMPLETE, A FOLLOW UP REPORT WILL BE SENT.
Description of Event or Problem · 1
IT WAS REPORTED WHILE USING THE CATHETER DURING AN ABLATION PROCEDURE, THE IRRIGATION LINE BROKE. THERE WERE NO CONSEQUENCES TO THE PATIENT. THE STATUS OF THE PATIENT WAS LISTED AS STABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COOL PATH DUO 7F, 1304-CP2-7-1.5(5)-L1-TE4BE1AB | THERAPY COOL PATH ABLATION | OAD | ST. JUDE MEDICAL, IRVINE | 83565 | 3189279 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR |