FDA Adverse Event
Injury
Summary report: N
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
MDR report key: 1192097
·
Received October 7, 2008
Report
- Report Number
- 2953144-2008-01641
- Event Type
- Injury
- Date Received
- October 7, 2008
- Date of Event
- August 21, 2008
- Report Date
- September 16, 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
- SC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE.
Description of Event or Problem · 1
DEVICE MALFUNCTION: UNK DEVICE FAILURE. TIME OF MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE: NONE: FAILURE TO ACHIEVE HEMOSTASIS. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE RIGHT FEMORAL ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE DEVICE WAS "DEFECTIVE". HEMOSTASIS WAS ACHIEVED USING MANUAL COMPRESSION. THERE WERE NO REPORTED PT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFO WAS AVAILABLE.
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 | 67107-6H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |