FDA Adverse Event
Injury
Summary report: N
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
MDR report key: 1850775
·
Received September 28, 2010
Report
- Report Number
- 2953144-2010-02060
- Event Type
- Injury
- Date Received
- September 28, 2010
- Date of Event
- September 3, 2010
- Report Date
- September 3, 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
- AS
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PHYSICIAN NOT TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF A COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, WHEN THE PLUNGER WAS COMPLETELY PUSHED DOWN, IT FELT AS IF IT WAS NOT CORRECTLY ENGAGED. UPON REMOVAL OF THE PLUNGER, THE SUTURE WAS NOT ATTACHED. THE DEVICE WAS REMOVED FROM THE ANATOMY AND THE SUTURE WAS FOUND TO HAVE HAD PASSED THROUGH THE ARTERY, BUT THE KNOT WAS INCOMPLETE. AN UNSUCCESSFUL ATTEMPT WAS MADE TO ACHIEVE HEMOSTASIS BY MANUALLY TYING A SLIPKNOT. A CUT DOWN WAS PERFORMED TO CLOSE THE ARTERY. NO ADVERSE PT SEQUELA WAS REPORTED. NO ADDITIONAL INFO 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-VASCULAR SOLUTIONS | NA | 910096H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |