MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-06-04 for HEMOCLIP 52380 UNK manufactured by Weck.
[360331]
A few hours after a five vessel coronary artery bypass graft, the pt developed chest tube drainage that progressed toward cardiac tamponade. While awaiting transfer to the or pt self-extubated and in spite of prolonged cpr was in prolonged cardiac arrest. Patient's chest was re-opened, open massage carried out and pt was placed on bypass. Approximately 100cc clot posterior to the heart was observed, and a bleed-site found on a posterior graft which was repaired. The pt had suffered severe anoxic brain injury and developed cerebral edema with brain stem herniation. Pt's support was withdrawn and pt was allowed to expire. Causative factors in the pt's death were hemorrhage and loss of airway.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 528884 |
| MDR Report Key | 528884 |
| Date Received | 2004-06-04 |
| Date of Report | 2004-06-03 |
| Date of Event | 2004-05-04 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | 52380 |
| 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 | 518072 |
| Manufacturer | WECK |
| Manufacturer Address | 2917 WECK DR RESEARCH TRIANGLE PARK NC * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2004-06-04 |