RELIANT BALLOON Adverse Event — Malfunction (MDR 9612164-2020-01695)
RELIANT BALLOON Adverse Event — Malfunction (MDR 9612164-2020-01695) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: RELIANT BALLOON; Generic name: CATHETER, PERCUTANEOUS; Manufacturer: MEDTRONIC IRELAND.
| Device | RELIANT BALLOON |
|---|---|
| Generic name | CATHETER, PERCUTANEOUS |
| Manufacturer | MEDTRONIC IRELAND |
| Report number | 9612164-2020-01695 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | ADDITIONAL INFORMATION RECEIVED, IT WAS REPORTED THAT DURING THE USE OF THE RELIANT FOR EXPANSION OF VASCULAR PROTHESIS, THE PHYSICIAN ALSO ENCOUNTERED ANEURYSM RUPTURES (THESE WERE PATIENTS WITH CALCIFIED VESSELS). THE PHYSICIAN FOUND THESE EVENTS VERY CONCERNING, SOMEWHAT CONCERNING AND NOT AT ALL CONCERNING. THESE EVENTS WERE FOUND TO BE RELATED TO THE DEVICE ON AT LEAST ONE OCCASION. METHOD/RE |
| Source | openFDA MAUDE (device adverse events) |
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