STARCLOSE VASCULAR CLOSURE SYSTEM Adverse Event — Malfunction (MDR 2953144-2008-00079)
STARCLOSE VASCULAR CLOSURE SYSTEM Adverse Event — Malfunction (MDR 2953144-2008-00079) 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: 2953144-2008-00079.
| Device | STARCLOSE VASCULAR CLOSURE SYSTEM |
|---|---|
| Manufacturer | ABBOTT VASCULAR-VASCULAR SOLUTIONS |
| Report number | 2953144-2008-00079 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2008-02-18 |
| Report source | Foreign, Health Professional, Company representation |
| Narrative | DEVICE MALFUNCTION: CLIP MISLOCATION. TIME OF MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE: NONE. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE STARCLOSE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF AN UNSPECIFIED SITE AFTER AN INTERVENTIONAL PROCEDURE. THE CLIP WAS DEPLOYED AND THE DEVICE WAS REMOVED FROM THE ARTERIOTOMY WITHOUT INCIDENT. AFTER REMOVAL, THE STARCLOSE CLIP WAS NOTED TO |
| Source | openFDA MAUDE (device adverse events) |
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