FDA Adverse Event
Injury
Summary report: N
STARCLOSE SE VASCULAR CLOSURE SYSTEM
MDR report key: 1844675
·
Received September 23, 2010
Report
- Report Number
- 2953144-2010-02036
- Event Type
- Injury
- Date Received
- September 23, 2010
- Report Date
- August 30, 2010
- Manufacturer
- ABBOTT VASCULAR - VASCULAR SOLUTIONS
- Product Code
- MGB
- PMA / PMN Number
- P050007
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVAL. IT HAS NOT YET BEEN RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PHYSICIAN, UNSPECIFIED IF TRAINED IN THE USE OF THE STARCLOSE SE DEVICE, ATTEMPTED ARTERIOTOMY CLOSURE OF AN UNSPECIFIED VESSEL AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, EXCESSIVE RESISTANCE WAS FELT WHEN ADVANCING THE THUMB ADVANCER AND THE SHEATH FAILED TO SPLIT COMPLETELY. THE DEVICE WAS REMOVED USING THE SAFETY RELEASE BUTTON. HEMOSTASIS WAS ACHIEVED USING MANUAL COMPRESSION. THERE WERE NO REPORTED ADVERSE PT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STARCLOSE SE VASCULAR CLOSURE SYSTEM | MGB | ABBOTT VASCULAR - VASCULAR SOLUTIONS | NA | 86016-6H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |