MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-11 for ZIPWIRE 630-208B manufactured by Boston Scientific Corporation.
[64450421]
Patient Sequence No: 1, Text Type: N, H10
[64450422]
The pt was admitted for percutaneous nephrolithotomy (pcnl). The surgeon used a hydrophilic guidewire to access a nephrostomy site, when he withdrew the wire it was discovered a segment of the outer coating was stripped off. An unsuccessful attempt was made to remove this segment. The procedure was aborted due to poor access.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6240553 |
| MDR Report Key | 6240553 |
| Date Received | 2017-01-11 |
| Date of Report | 2016-11-22 |
| Date of Event | 2016-10-14 |
| Report Date | 2016-11-22 |
| Date Reported to FDA | 2016-11-22 |
| Date Reported to Mfgr | 2016-11-22 |
| Date Added to Maude | 2017-01-11 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 3 |
| Brand Name | ZIPWIRE |
| Generic Name | CATHETER INTRODUCER KIT |
| Product Code | OFC |
| Date Received | 2017-01-11 |
| Model Number | 630-208B |
| Device Availability | N |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | 500 COMMANDER SHEA BOULEVARD QUINCY MA 02171 US 02171 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-11 |