SMART CONTROL NITINOL STENT SYSTEM Adverse Event — Malfunction (MDR 9616099-2008-00373)
SMART CONTROL NITINOL STENT SYSTEM Adverse Event — Malfunction (MDR 9616099-2008-00373) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: SMART CONTROL NITINOL STENT SYSTEM; Generic name: SELF EXPANDING STENTS (FGE); Manufacturer: CORDIS DE MEXICO.
| Device | SMART CONTROL NITINOL STENT SYSTEM |
|---|---|
| Generic name | SELF EXPANDING STENTS (FGE) |
| Manufacturer | CORDIS DE MEXICO |
| Report number | 9616099-2008-00373 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2008-02-15 |
| Report source | Foreign, Health Professional, Company representation |
| Narrative | THE ORIGINAL COMPLAINT RECEIVED STATES THAT THERE WAS A KINK FOUND NEAR THE HANDLE OF THE STENT DELIVERY SYSTEM. IT WAS NOTICED WHEN OPENING THE PACKAGING. THE PACKAGING WAS INTACT BEFORE BEING OPENED. THE PRODUCT WAS NOT USED IN THE PT. THE PRODUCT WAS RETURNED FOR EVALUATION AND TESTING. THE PRODUCT WAS RECEIVED COILED IN A PLASTIC BAG. THE ANALYSIS SHOWED THAT THE OUTER BODY WAS BROKEN, BUT NOT |
| Source | openFDA MAUDE (device adverse events) |
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