MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-09 for BOSTON SCIENTIFIC PT2 GUIDEWIRE H74938931030 manufactured by Boston Scientific Cardiology.
[33474320]
(b)(6) male presents with abnormal stress myoview for elective cardiac catheterization and percutaneous coronary intervention. Distal wire fracture noted after stent deployment with significant pericardial "blush". Echo post procedure revealed significant pericardial blood with tamponade. Patient taken emergently to cvor for pericardial window. Right ventricle failed during procedure and pt developed cardiac arrest. Pt expired despite aggressive acls measures. Guidewire 1. 7cm shorter with slight curvature at end when measured and compared to a new intact wire. Notification on 12/04/2015 to (b)(4), boston scientific coronary representative (b)(4), notification forwarded to scientific complaints dept (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5292459 |
| MDR Report Key | 5292459 |
| Date Received | 2015-12-09 |
| Date of Report | 2015-12-04 |
| Date of Event | 2015-11-13 |
| Date Facility Aware | 2015-11-13 |
| Report Date | 2015-12-04 |
| Date Reported to FDA | 2015-12-04 |
| Date Reported to Mfgr | 2015-12-04 |
| Date Added to Maude | 2015-12-14 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 0 |
| Brand Name | BOSTON SCIENTIFIC |
| Generic Name | MOD SUPPORT STRAIGHT TIP GUIDEWIRE |
| Product Code | NKQ |
| Date Received | 2015-12-09 |
| Model Number | PT2 GUIDEWIRE |
| Catalog Number | H74938931030 |
| Lot Number | 18464862 |
| Device Expiration Date | 2017-09-29 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 0 DA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CARDIOLOGY |
| Manufacturer Address | ONE SCIMED PLACE MAPLE GROVE MN 55311 US 55311 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2015-12-09 |