FDA Adverse Event
Injury
Summary report: N
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
MDR report key: 1851828
·
Received September 29, 2010
Report
- Report Number
- 2953144-2010-02341
- Event Type
- Injury
- Date Received
- September 29, 2010
- Date of Event
- August 30, 2010
- Report Date
- September 6, 2010
- Manufacturer
- ABBOTT VASCULAR-VASCULAR SOLUTIONS
- 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
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE WAS REC'D. INVESTIGATION IS NOT COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PHYSICIAN, USING THE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF AN UNSPECIFIED VESSEL AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, THE 'PROGLIDE COULD NOT BE INTRODUCED'. THE METHOD USED TO ACHIEVE HEMOSTASIS WAS NOT REPORTED. THERE WERE NO REPORTED ADVERSE PT EFFECTS. THOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM | MGB | ABBOTT VASCULAR-VASCULAR SOLUTIONS | NA | 90026-6H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Required Intervention |