FDA Adverse Event
Injury
Summary report: N
STARCLOSE VASCULAR CLOSURE SYSTEM
MDR report key: 1040171
·
Received May 8, 2008
Report
- Report Number
- 2953144-2008-00863
- Event Type
- Injury
- Date Received
- May 8, 2008
- Date of Event
- April 9, 2008
- Report Date
- April 15, 2008
- Manufacturer
- ABBOTT VASCULAR REDWOOD CITY
- Product Code
- MGB
- PMA / PMN Number
- P050007
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED.
Description of Event or Problem · 1
DEVICE MALFUNCTION: DIFFICULT TO REMOVE. TIME OF DEVICE MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE: FAILURE TO ACHIEVE HEMOSTASIS. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE STARCLOSE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, AFTER THE FOURTH CLICK THE DEVICE BECAME STUCK IN THE WOUND TRACT. THE DEVICE WAS REMOVED USING COUNTER-TENSION AND HEMOSTASIS WAS ACHIEVED USING MANUAL COMPRESSION. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. THROUGH REQUESTED, NO ADDITIONAL INFORMATION WAS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STARCLOSE VASCULAR CLOSURE SYSTEM | MGB | ABBOTT VASCULAR REDWOOD CITY | NA | 62173-6H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR | Required Intervention |