MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-06-04 for HEMOCLIP 523800 UNK manufactured by Weck.
[360332]
Pt received a triple coronary artery bypass graft and aortic valve replacement with no intraoperative complications. Upon arrival in cicu hemorrhage was visible through the chest tube accompanied by a percipitous drop in blood pressure. The pt was reopened and massive hemorrhaging and cardiac tamponade observed. Surgical clips were missing from two branches of the rt coronary artery. The pt expired after 30 minutes of open cardiac resuscitation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 528889 |
| MDR Report Key | 528889 |
| Date Received | 2004-06-04 |
| Date of Report | 2004-06-03 |
| Date of Event | 2004-04-28 |
| Date Facility Aware | 2004-05-18 |
| Report Date | 2004-06-03 |
| Date Reported to FDA | 2004-06-03 |
| Date Reported to Mfgr | 2004-06-03 |
| Date Added to Maude | 2004-06-10 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEMOCLIP |
| Generic Name | TITANIUM LIGATING CLIP |
| Product Code | DSS |
| Date Received | 2004-06-04 |
| Model Number | 523800 |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 518077 |
| Manufacturer | WECK |
| Manufacturer Address | * RESEARCH TRIANGLE PARK NC * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2004-06-04 |