MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-04 for WIRE JAGWORE STRAINGHT TIP .025 X 450CM manufactured by Boston Scientific Corporation.
[178025731]
Ercp was being performed with placement of bilateral stents, upon removal of catheters, one of the guide wires used to deploy the stent sheared on the stent and a portion of guide wire remained in bile duct. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092773 |
| MDR Report Key | 9672076 |
| Date Received | 2020-02-04 |
| Date of Report | 2020-01-31 |
| Date of Event | 2020-01-29 |
| Date Added to Maude | 2020-02-05 |
| 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 |
| 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 | WIRE JAGWORE STRAINGHT TIP .025 X 450CM |
| Generic Name | STYLET FOR CATHETER, GASTRO-UROLOGY |
| Product Code | EZB |
| Date Received | 2020-02-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Brand Name | STENTS, DRAIN AND DILATORS FOR BILIARY DUCTS |
| Generic Name | STENTS, DRAIN AND DILATORS FOR BILIARY DUCTS |
| Product Code | FGE |
| Date Received | 2020-02-04 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-04 |