CRE PRO GI Adverse Event — Malfunction (MDR 3005099803-2020-01741)
CRE PRO GI Adverse Event — Malfunction (MDR 3005099803-2020-01741) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: CRE PRO GI; Generic name: DILATOR, ESOPHAGEAL; Manufacturer: BOSTON SCIENTIFIC CORPORATION.
| Device | CRE PRO GI |
|---|---|
| Generic name | DILATOR, ESOPHAGEAL |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Report number | 3005099803-2020-01741 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | (B)(4). INVESTIGATION RESULTS: VISUAL EXAMINATION OF THE RETURNED COMPLAINT DEVICE FOUND THE BALLOON DID NOT SHOW VISUAL DEFECTS AND WAS IN A GOOD CONDITION. NO DAMAGE FOUND ON THE CATHETER OF THE DEVICE. FUNCTIONAL ANALYSIS WAS PERFORMED, AND THE BALLOON WAS INFLATED WITHOUT A PROBLEM; HOWEVER, THE BALLOON WOULD NOT HOLD PRESSURE DUE TO A PINHOLE IN THE DISTAL SECTION ON THE BODY OF THE BALLOON. |
| Source | openFDA MAUDE (device adverse events) |
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