SI AVANTI+ 6F STD W/GW NO OBT Adverse Event — Malfunction (MDR 9616099-2020-03672)
SI AVANTI+ 6F STD W/GW NO OBT Adverse Event — Malfunction (MDR 9616099-2020-03672) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: SI AVANTI+ 6F STD W/GW NO OBT; Generic name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION; Manufacturer: CORDIS CORPORATION.
| Device | SI AVANTI+ 6F STD W/GW NO OBT |
|---|---|
| Generic name | DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION |
| Manufacturer | CORDIS CORPORATION |
| Report number | 9616099-2020-03672 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | AS REPORTED, THE 6F STANDARD (STD) AVANTI PLUS CATHETER SHEATH INTRODUCER (CSI) WITH GUIDEWIRE (GW) NO OBTURATOR (OBT) SNAPPED INSIDE THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED AND THE CANNULA WAS RECEIVED SEPARATED AT 1.9 CM FROM THE HUB, THE OTHER PORTION OF THE SEPARATED PART WAS NOT RECEIVED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS RETURNED FOR ANALYSIS. ONE NON-STERILE SI A |
| Source | openFDA MAUDE (device adverse events) |
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