FDA Adverse Event
Injury
Summary report: N
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
MDR report key: 1063205
·
Received June 19, 2008
Report
- Report Number
- 2953144-2008-01063
- Event Type
- Injury
- Date Received
- June 19, 2008
- Date of Event
- May 27, 2008
- Report Date
- May 28, 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
- AS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE.
Description of Event or Problem · 1
DEVICE MALFUNCTION: MARKER LUMEN BLOCKAGE. 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 AN UNSPECIFIED VESSEL AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, WHEN DELIVERING THE DEVICE THERE WAS NO BLEEDBACK THROUGH THE MARKER LUMEN. THE DEVICE WAS REMOVED AND THE MARKER LUMEN WAS FLUSHED AND RE-INSERTED INTO THE ARTERY, BUT ONCE AGAIN DID NOT DEMONSTRATE ANY BLEEDBACK. THE DEVICE WAS THEN REMOVED FROM THE PT INTACT AND A 6FR ANGIOSEAL WAS USED TO ACHIEVE HEMOSTASIS. NO ADD'L 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 | 63174-6H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |