INTERLOCK Adverse Event — Malfunction (MDR 2134265-2020-05620)
INTERLOCK Adverse Event — Malfunction (MDR 2134265-2020-05620) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: INTERLOCK; Generic name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION; Manufacturer: BOSTON SCIENTIFIC CORPORATION.
| Device | INTERLOCK |
|---|---|
| Generic name | DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Report number | 2134265-2020-05620 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, DISTRI |
| Narrative | IT WAS REPORTED THAT COIL PROTRUSION OCCURRED. THE TARGET LESION AREA WAS LOCATED IN A MODERATELY TORTUOUS VESSEL IN THE ABDOMEN. A 2D 3MMX12CM INTERLOCK PE F-IDC EMBOLIC, A 2D 6MMX20CM INTERLOCK PE F-IDC EMBOLIC, AND 2 2D 4MMX15CM INTERLOCK PE F-IDC EMBOLICS WERE ATTEMPTED TO BE USED DURING AN ENDOLEAK PREVENTION PROCEDURE WITHIN THE ABDOMEN. DURING THE PROCEDURE, THE COILS BECAME STUCK INSIDE TH |
| Source | openFDA MAUDE (device adverse events) |
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