MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-17 for BIOGLUE - UNKNOWN CONFIGURATION BG UNK manufactured by Cryolife, Inc..
[176843912]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report. This report is being submitted as required by federal regulations and does not constitute an admission that the device caused or contributed to the reported event. Furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to cryolife is accurate or has been confirmed by cryolife.
Patient Sequence No: 1, Text Type: N, H10
[176843913]
Journal article: wang, w et al. Third ventricle floor bowing: a useful measurement to predict endoscopic third ventriculostomy success in infantile hydrocephalus. " acta neurochirugica (2019): epub. A study where 42 hydrocephalic infants with third ventricle floor bowing were treated endoscopically between jan 2013 and apr 2018. To avoid postoperative csf leak and subdural collections, corticle hole was blocked with absorbable gelatin sponge and bioglue. While the article does not conclude that the posteropative complications from the study were attributed to bioglue, the following complications included seizure (2. 4%), csf leak (2. 4%), and subdural effusion (2. 4%). Post operative complications: hemorrhage, infection, csf leak, and new neurological deficit.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2020-00080 |
| MDR Report Key | 9601466 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-17 |
| Date of Report | 2020-02-20 |
| Date Mfgr Received | 2020-01-08 |
| Date Added to Maude | 2020-01-17 |
| 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. |
| Manufacturer City | KENNESAW GA 30144 |
| Manufacturer Country | US |
| Manufacturer Postal | 30144 |
| Manufacturer Phone | 7704193355 |
| Manufacturer G1 | CRYOLIFE, INC. |
| Manufacturer Street | 1655 ROBERTS BLVD. |
| 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 - UNKNOWN CONFIGURATION |
| Generic Name | GLUE, SURGICAL, ARTERIES |
| Product Code | MUQ |
| Date Received | 2020-01-17 |
| Model Number | BG UNK |
| 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. Hospitalization | 2020-01-17 |