FDA Adverse Event
Malfunction
Summary report: N
COOL PATH 7F, 1304-CP-7-25-M
MDR report key: 2063122
·
Received March 22, 2011
Report
- Report Number
- 2030404-2011-00082
- Event Type
- Malfunction
- Date Received
- March 22, 2011
- Date of Event
- February 23, 2011
- Report Date
- February 23, 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, A FOLLOW-UP REPORT WILL BE SUBMITTED WITH OUR INVESTIGATION RESULTS.
Description of Event or Problem · 1
IT WAS REPORTED AFTER INSERTION INTO THE PATIENT THE IRRIGATION TUBE BROKE CAUSING SALINE TO LEAK. THERE WERE NO CONSEQUENCES TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COOL PATH 7F, 1304-CP-7-25-M | NONE | OAD | ST. JUDE MEDICAL, IRVINE | 83352 | 3228946 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |