MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-24 for BOSTON SCIENTIFIC RX LOCKING DEVICE AND CAP manufactured by Boston Scientific Corp..
[131765174]
A boston scientific rx locking device and cap was used in a routine ercp. The cap has a small white sponge inside of it meant to keep bile from refluxing back out the cap during the procedure. During the case, the sponge was pushed inadvertently into the scope channel causing an obstruction. The obstruction was noted immediately, the scope removed from the patient and endoscopy suite. No harm to patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5082564 |
| MDR Report Key | 8196356 |
| Date Received | 2018-12-24 |
| Date of Report | 2018-12-21 |
| Date of Event | 2018-06-28 |
| Date Added to Maude | 2018-12-26 |
| 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 | BOSTON SCIENTIFIC RX LOCKING DEVICE AND CAP |
| Generic Name | ENDOSCOPE CHANNEL ACCESSORY |
| Product Code | ODC |
| Date Received | 2018-12-24 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORP. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-24 |