FDA Adverse Event
Malfunction
Summary report: N
COOL PATH 7F CATH., 1304-CP-7-25-L CATHETER (USA)
MDR report key: 1881989
·
Received October 12, 2010
Report
- Report Number
- 2030404-2010-00186
- Event Type
- Malfunction
- Date Received
- October 12, 2010
- Date of Event
- September 10, 2010
- Report Date
- September 14, 2010
- Manufacturer
- ST. JUDE MEDICAL, IRVINE
- Product Code
- OAD
- PMA / PMN Number
- P060019
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
WE ARE AWAITING DEVICE RETURN. WHEN OUR EVALUATION HAS BEEN COMPLETED A FOLLOWUP REPORT WILL BE SUBMITTED. DATE REPORT SUBMITTED TO FDA BY MANUFACTURER: 10/12/2010. DATE THE INITIAL REPORTER PROVIDED THE INFORMATION TO THE MANUFACTURER: (B)(4) 2010.
Description of Event or Problem · 1
IT WAS REPORTED THE CATHETER HAD A HANDLE LEAK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COOL PATH 7F CATH., 1304-CP-7-25-L CATHETER (USA) | NONE | OAD | ST. JUDE MEDICAL, IRVINE | 83327 | K28766 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |