FDA Adverse Event
Death
Summary report: N
BIOGLUE SURGICAL ADHESIVE
MDR report key: 513101
·
Received February 25, 2004
Report
- Report Number
- 1063481-2004-00001
- Event Type
- Death
- Date Received
- February 25, 2004
- Report Date
- January 26, 2004
- Manufacturer
- CRYOLIFE, INC.
- Product Code
- MFI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
ACCORDING TO LIMITED INFO, BIOGLUE SURGICAL ADHESIVE WAS USED DURING REPAIR OF AN AORTIC DISSECTION AT APPROXIMATELY 2.5 YEARS AGO: HOWEVER, SPECIFIC INFO ABOUT THE PT HAS NOT BEEN PROVIDED TO THE MFR TO DATE. THE SURGEON HAS INDICATED THAT BIOGLUE SURGICAL ADHESIVE WAS DISCOVERED IN THE POSTERIOR CEREBRAL CIRCULATION AT AUTOPSY. IT WAS INDICATED THAT THE SURGEON DOES NOT REGULARLY USE BALLOON OCCLUSION OF THE DISTAL AORTA DURING APPLICATION OF THE SURGICAL ADHESIVE IN A DISSECTION REPAIR AS PER THE PRODUCT'S INSTRUCTIONS FOR USE. HOWEVER, IT WAS INDICATED THAT THE AREA IS ROUTINELY PROTECTED WITH SURGICAL SPONGES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIOGLUE SURGICAL ADHESIVE | SURGICAL ADHESIVE | MFI | CRYOLIFE, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Death |