PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
Report
- Report Number
- 2953144-2008-01382
- Event Type
- Injury
- Date Received
- August 22, 2008
- Date of Event
- August 4, 2008
- Report Date
- August 7, 2008
- Manufacturer
- ABBOTT VASCULAR 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
- SZ
- Reporter Occupation
- PHYSICIAN
Narratives
THE DEVICE IS EXPECTED TO BE RETURNED FOR EVAL. IT HAS NOT YET BEEN RECEIVED. DEVICE#1: PERCLOSE PROGLIDE, PART# 12673-03, LOT# 66135-6H, INDICATED IS BEING FILED UNDER MEDWATCH MFR# 2953144-2008-01381. DEVICE# 3: PERCLOSE PROGLIDE, PART# 12673-03, LOT# 66135-6H, IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER.
DEVICE MALFUNCTION: DEVICE# 2 SUTURE RETRIEVAL. TIME OF MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE: FAILURE TO ACHIEVE HEMOSTASIS. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, UPON PLUNGER WITHDRAWAL, NO SUTURE WAS PRESENT. A SECOND AND THIRD PROGLIDE DEVICE WERE ATTEMPTED WITH THE SAME RESULTS. HEMOSTASIS WAS ACHIEVED USING MANUAL COMPRESSION. THERE WERE NO REPORTED ADVERSE PT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL 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 REDWOOD CITY | NA | 66135-6H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | LOT# 66135-6H| LOT# 66135-6H| DEVICE #1: PERCLOSE PROGLIDE PART# 12673-03| DEVICE#3: PERCLOSE PROGLIDE PART# 12673-03 |