MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-03 for ZIPWIRE HYDROPHILIS GUIDEWIRE 087147297640 M00146301B0 manufactured by Boston Scientific Corporation.
[141067273]
Pt was having a port-a-cath placed in the operating room. Disposable zipwire was used and threaded through introducer for guidance. Upon removal of the guidewire, sheath was frayed at the tip about 8 inches down; half of the side remained in the pt. Xray confirmed sheath was inside pt. With xray guidance surgeon was able to remove the piece from the pt. This required extended operating room time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5085592 |
| MDR Report Key | 8483239 |
| Date Received | 2019-04-03 |
| Date of Report | 2019-03-21 |
| Date of Event | 2019-03-20 |
| Date Added to Maude | 2019-04-04 |
| 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 | ZIPWIRE HYDROPHILIS GUIDEWIRE |
| Generic Name | CATHETER INTRODUCER KIT |
| Product Code | OFC |
| Date Received | 2019-04-03 |
| Model Number | 087147297640 |
| Catalog Number | M00146301B0 |
| Lot Number | 10820906 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-04-03 |