STARCLOSE VASCULAR CLOSURE SYSTEM Adverse Event — Injury (MDR 2953144-2008-00075)
STARCLOSE VASCULAR CLOSURE SYSTEM Adverse Event — Injury (MDR 2953144-2008-00075) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: STARCLOSE VASCULAR CLOSURE SYSTEM; Manufacturer: ABBOTT VASCULAR - VASCULAR SOLUTIONS; Report number: 2953144-2008-00075.
| Device | STARCLOSE VASCULAR CLOSURE SYSTEM |
|---|---|
| Manufacturer | ABBOTT VASCULAR - VASCULAR SOLUTIONS |
| Report number | 2953144-2008-00075 |
| Event type | Injury |
| Product problem | N |
| Date received | 2008-02-15 |
| Report source | Foreign, Health Professional, Company representation |
| Narrative | DEVICE MALFUNCTION: DIFFICULT TO REMOVE. TIME OF MALFUNCTION SYMPTOMS/AE: DURING VESSEL CLOSURE. SYMPTOMS/AE: DEVICE SURGICALLY REMOVED. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE STARCLOSE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF A SCARRED FEMORAL ARTERY AFTER AN UNSPECIFIED PROCEDURE. AFTER THE CLIP WAS DEPLOYED THE PHYSICIAN ATTEMPT TO RETRACT THE DEVICE BUT IT BECAME STUCK AND C |
| Source | openFDA MAUDE (device adverse events) |
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