FDA Adverse Event
Injury
Summary report: N
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
MDR report key: 1080411
·
Received July 22, 2008
Report
- Report Number
- 2953144-2008-01226
- Event Type
- Injury
- Date Received
- July 22, 2008
- Date of Event
- June 18, 2008
- Report Date
- June 30, 2008
- Manufacturer
- ABBOTT VASCULAR INC.- REDWOOD CITY
- Product Code
- MGB
- PMA / PMN Number
- P960043
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN RETURNED. INVESTIGATION IS NOT COMPLETE.
Description of Event or Problem · 1
DEVICE MALFUNCTION: SUTURE RETRIEVAL. TIME OF MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE: FAILURE TO ACHIEVE HEMOSTASIS. IT WAS REPORTED THAT A TRAINED PHYSICIAN ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY USING THE PROGLIDE DEVICE AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE SUTURE DID NOT CATCH. A SECOND PROGLIDE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED PT EFFECTS. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM | MGB | ABBOTT VASCULAR INC.- REDWOOD CITY | NA | 65106-6H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |