FDA Adverse Event
Injury
Summary report: N
STARCLOSE SE VASCULAR CLOSURE SYSTEM
MDR report key: 1872908
·
Received October 14, 2010
Report
- Report Number
- 2953144-2010-02467
- Event Type
- Injury
- Date Received
- October 14, 2010
- Date of Event
- September 21, 2010
- Report Date
- September 22, 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
- IL, US
- Reporter Occupation
- PHYSICIAN
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 TRAINED IN THE USE OF THE STARCLOSE SE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, AFTER CLIP DEPLOYMENT, THE DEVICE WAS REMOVED; HOWEVER, THE CLIP WAS FOUND TO BE IN THE DISTAL END OF THE DEVICE. HEMOSTASIS WAS ACHIEVED USING MANUAL COMPRESSION. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. THOUGH REQUESTED, NO ADD'L 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 | 91005-6H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |