MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-11 for SPHINCTEROTOME HYDRATOME RX44 M00583040 manufactured by Boston Scientific Corporation.
[110910636]
Boston scientific hydratome rx44 sphincterotome wire did not bend when handle flexed while attempting to perform sphincterotomy. Hydratome removed from field and replaced with an autotome rx44 which was used to perform the sphincterotomy without problems.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5077774 |
| MDR Report Key | 7591149 |
| Date Received | 2018-06-11 |
| Date of Event | 2018-06-07 |
| Date Added to Maude | 2018-06-12 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | 0 |
| Brand Name | SPHINCTEROTOME HYDRATOME RX44 |
| Generic Name | STYLET FOR CATHETER, GASTRO-UROLOGY |
| Product Code | EYA |
| Date Received | 2018-06-11 |
| Catalog Number | M00583040 |
| Lot Number | 22043341 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-11 |