FDA Adverse Event
Injury
Summary report: N
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
MDR report key: 1060671
·
Received June 13, 2008
Report
- Report Number
- 2953144-2008-01049
- Event Type
- Injury
- Date Received
- June 13, 2008
- Date of Event
- April 1, 2008
- Report Date
- May 21, 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
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN RECEIVED. INVESTIGATION IS NOT COMPLETE.
Description of Event or Problem · 1
DEVICE MALFUNCTION: SUTURE BREAK. TIME OF MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE: FAILURE TO ACHIEVE HEMOSTASIS. IT WAS REPORTED THAT ARTERIOTOMY CLOSURE WAS ATTEMPTED USING THE PROGLIDE DEVICE AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, "PRESSURE WAS PUT ON THE SUTURES RESULTING IN SUTURE BREAKAGE" . HEMOSTASIS WAS ACHIEVED WITH AN ANGIOSEAL. THERE WERE NO ADVERSE PATIENT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFORMATION 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 | 58106-6H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |