BARD INLAY OPTIMA URETERAL STENT WITH HYDROGLIDE GUIDEWIRE Adverse Event — Malfunction (MDR 1018233-2020-02910)
BARD INLAY OPTIMA URETERAL STENT WITH HYDROGLIDE GUIDEWIRE Adverse Event — Malfunction (MDR 1018233-2020-02910) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: BARD INLAY OPTIMA URETERAL STENT WITH HYDROGLIDE GUIDEWIRE; Generic name: URETERAL STENT; Manufacturer: C.R. BARD, INC.
| Device | BARD INLAY OPTIMA URETERAL STENT WITH HYDROGLIDE GUIDEWIRE |
|---|---|
| Generic name | URETERAL STENT |
| Manufacturer | C.R. BARD, INC. (COVINGTON) -1018233 |
| Report number | 1018233-2020-02910 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | DISTRIBUTOR, OTHER |
| Narrative | THE REPORTED EVENT WAS CONFIRMED. BASED ON THE EVALUATION, IT WAS OBSERVED THAT THE GREEN STENT WAS BROKEN AT TAIL AREA. THE AREA OF THE BREAKAGE WAS EVALUATED UNDER MICROSCOPE AND NOTED TO BE SMOOTH TEAR. HOWEVER, SAMPLE HAS BEEN SENT TO SUPPLIER FOR FURTHER INVESTIGATION. THE POTENTIAL ROOT CAUSES FOR THIS FAILURE MODE COULD BE USER RELATED OR SUPPLIER RELATED (HANDLING ISSUE)/DESIGN ISSUE (IN A |
| Source | openFDA MAUDE (device adverse events) |
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