FDA Adverse Event
Summary report: N
PROGLIDE
MDR report key: 3220895
·
Received July 5, 2013
Report
- Report Number
- 3220895
- Date Received
- July 5, 2013
- Date of Event
- June 22, 2013
- Report Date
- July 5, 2013
- Manufacturer
- ABBOTT VASCULAR
- Product Code
- MGB
- Report Source
- User Facility report
- Reporter Location
- CA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
AFTER HEART CATH, THE MD USED A PROGLIDE CLOSURE SYSTEM TO CLOSE THE RIGHT FEMORAL ARTERIAL PUNTURE SITE. IMMEDIATELY AFTER THAT, WHILE THE PATIENT WAS STILL IN THE PROCEDURE ROOM, IT WAS NOTED THAT THE THE RIGHT PEDAL PULSES WERE NO LONGER PALPABLE. PRE-PROCEDURE THE PEDAL PULSES WERE +2. THE LEFT FEMORAL ARTERY WAS ACCESSED BY MD AND ANGIO OF RIGHT FEMORAL ARTERY REVEALED A NAPKIN RING STENOSIS WHICH WAS NOT PRESENT PRIOR TO DEPLOYMENT OF ARTERIAL CLOSURE DEVICE. CLOT ASPIRATION AND ANGIOPLASTY WERE PERFORMED AND CIRCULATION WAS RESTORED TO PRE-PROCEDURE ASSESSMENT.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?CLOSURE OF THE RIGHT FEMORAL ARTERIAL PUNCTURE SITE.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 307061 | PROGLIDE | DEVICE, HEMOSTASIS, VASCULAR | MGB | ABBOTT VASCULAR | * | 30306K1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR |