FDA Adverse Event
Malfunction
Summary report: N
MEDTRONIC PIGTAIL CARDIAC CASCADE UHF NWB
MDR report key: 55142
·
Received December 10, 1996
Report
- Report Number
- 1628221-1996-00011
- Event Type
- Malfunction
- Date Received
- December 10, 1996
- Date of Event
- October 15, 1996
- Report Date
- November 8, 1996
- Manufacturer
- MALLINCKRODT MEDICAL, INC.
- Product Code
- DQO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE ADDITIONAL INFO PROVIDED IN SECTION F WAS SUPPLIED BY MALLINCKRODT INC.
Description of Event or Problem · 1
THIS CATHETER WAS BEING UTILIZED FOR A DIAGNOSTIC CARDIOLOGY PROCEDURE WHEN IT KINKED. THERE WAS NO REPORTED INJURY TO THE PT. NOTE: THE EXACT LOT NUMBER OF THE CATHETER USED IN THE PROCEDURE WAS NOT KNOWN FOR CERTAIN. THREE POSSIBLE LOT MARKS WERE REPORTED. ADD'L EXPIRATION DATES ARE 6/30/99 AND 7/30/99 AND 7/31/99.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MEDTRONIC PIGTAIL CARDIAC CASCADE UHF NWB | DIAGNOSTIC INTRAVASCULAR CATHETER | DQO | MALLINCKRODT MEDICAL, INC. | NA | M256840,M282900,OR M290270 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |