MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-04 for ZIPWIRE HYDROPHILIC GUIDE REF# M00146152B0 manufactured by Boston Scientific.
[74741498]
Zipwire hydrophilic guide wire removed from patient was not intact; ref# m00146152b0, lot # 10803204, exp 2020-02-29; dr. And present from 1314 to 1322, wire fragment not retrieved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5069608 |
| MDR Report Key | 6551211 |
| Date Received | 2017-05-04 |
| Date of Report | 2017-05-04 |
| Date of Event | 2017-04-25 |
| Date Added to Maude | 2017-05-08 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | ZIPWIRE HYDROPHILIC GUIDE |
| Generic Name | ZIPWIRE HYDROPHILIC GUIDE |
| Product Code | OFC |
| Date Received | 2017-05-04 |
| Catalog Number | REF# M00146152B0 |
| Lot Number | 10803204 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC |
| Manufacturer Address | MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-04 |