FDA Adverse Event
Injury
Summary report: N
PERCLOSE PROGLIDE, 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
MDR report key: 1032342
·
Received April 22, 2008
Report
- Report Number
- 2953144-2008-00772
- Event Type
- Injury
- Date Received
- April 22, 2008
- Date of Event
- March 17, 2008
- Report Date
- March 28, 2008
- Manufacturer
- ABBOTT VASCULAR REDWOOD CITY
- Product Code
- MGB
- PMA / PMN Number
- P960043
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETED.
Description of Event or Problem · 1
DEVICE MALFUNCTION: NONE. TIME OF DEVICE MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE: FAILURE TO ACHIEVE HEMOSTASIS. IT WAS REPORTED THAT A PHYSICIAN ATTEMPTED ARTERIOTOMY CLOSURE WITH A PROGLIDE DEVICE AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, AFTER FOOT DEPLOYMENT THE PHYSICIAN INADVERTENTLY PULLED THE PLUNGER OUT OF THE DEVICE BEFORE NEEDLE DEPLOYMENT OCCURRED. THE DEVICE WAS REMOVED WITHOUT DIFFICULTY AND HEMOSTASIS WAS ACHIEVED USING MANUAL COMPRESSION. THERE WERE NO REPORTED ADVERSE 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 | 60092-6H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Required Intervention | SHEATH: 6F 11CM| DIL CATH: VOYAGER |