MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-21 for NAVIGATOR HD M0062502290 manufactured by Boston Scientific Corporation.
[136730649]
Navigator hd was opened and soaked in water to be used in a ureteroscopy. The hydrophilic coating had rough areas that may have caused damage to the ureter if used.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8357215 |
| MDR Report Key | 8357215 |
| Date Received | 2019-02-21 |
| Date of Report | 2019-02-15 |
| Date of Event | 2019-02-13 |
| Report Date | 2019-02-15 |
| Date Reported to FDA | 2019-02-15 |
| Date Reported to Mfgr | 2019-02-21 |
| Date Added to Maude | 2019-02-21 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NAVIGATOR HD |
| Generic Name | ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY |
| Product Code | FED |
| Date Received | 2019-02-21 |
| Model Number | M0062502290 |
| Catalog Number | M0062502290 |
| Lot Number | 22969045 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | 780 BROOKSIDE DRIVE SPENCER IN 47460 US 47460 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-21 |