MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2019-04-23 for BIOGLUE SURGICAL ADHESIVE BG3510-5-J manufactured by Cryolife, Inc..
[142731027]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[142731028]
According to the initial report the patient had an aortic dissection. Bioglue was used to false lumen proximal end. The condition/integrity of the native tissue is unknown. Post operatively a pseudoaneurysm was confirmed on the false lumen proximal end close to rcc (right coronary cusp). (b)(6) operation followed as intervention. After the reoperation, endocarditis infective was confirmed; however patient refused to receive another operation. Patient's outcome: death. It is supposed from the doctor's experience in using bioglue that the appropriate amount was applied, the field was kept dry, and there was no problem in the actual use of the product. It is unknown if bioglue was used as an adjunct to sutures and if the vessel was clamped and depressurized prior to application of bioglue. Additional information according to the doctor, the tissue of the vessels was rather fragile for this patient. Causal relationship to the device is unknown, but cannot be completely denied either.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2019-00022 |
| MDR Report Key | 8539279 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2019-04-23 |
| Date of Report | 2019-06-17 |
| Date Mfgr Received | 2019-04-18 |
| Date Added to Maude | 2019-04-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | ROCHELLE MANEY |
| Manufacturer Street | 1655 ROBERTS BLVD. NW |
| Manufacturer City | KENNESAW GA 30144 |
| Manufacturer Country | US |
| Manufacturer Postal | 30144 |
| Manufacturer Phone | 7704193355 |
| Manufacturer G1 | CRYOLIFE, INC. |
| Manufacturer Street | 1655 ROBERTS BLVD. NW |
| Manufacturer City | KENNESAW GA 30144 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30144 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOGLUE SURGICAL ADHESIVE |
| Generic Name | GLUE,SURGICAL,ARTERIES |
| Product Code | MUQ |
| Date Received | 2019-04-23 |
| Model Number | BG3510-5-J |
| Lot Number | UNKNOWN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CRYOLIFE, INC. |
| Manufacturer Address | 1655 ROBERTS BLVD. KENNESAW GA 30144 US 30144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Hospitalization; 3. Life Threatening; 4. Required No Informationntervention | 2019-04-23 |