MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,litera report with the FDA on 2020-01-22 for BIOGLUE- UNKNOWN CONFIGURATION BG UNK manufactured by Cryolife, Inc..
[178124799]
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
[178124800]
A case report in the publication by singh, a. And wales, l. ,? Late sterile cyst formation following use of bioglue in carotid endarterectomy.? Book of abstracts? The european society for vascular surgery 58:6s1 (2019): e128. An (b)(6) female admitted to the hospital following left lacunar stroke with significant right arm weakness and dysarthria. The patient had undergone a right carotid endarterectomy 9 months before where bioglue was used along the suture line to aid hemostasis. Further examination showed soft tissue thickening surrounding the right internal carotid artery with irregular fluid accumulation. Surgical exploration of the right neck was performed. Chronic inflammation and a superficial abscess was found. A large amount of bioglue with 1 cm of the distal patch seemed to be the central focus. All microbiological analysis was negative, and the patient was discharged to a stroke rehabilitation unit.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2020-00081 |
| MDR Report Key | 9617304 |
| Report Source | COMPANY REPRESENTATIVE,LITERA |
| Date Received | 2020-01-22 |
| Date of Report | 2020-03-17 |
| Date Mfgr Received | 2020-01-02 |
| Date Added to Maude | 2020-01-22 |
| 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- UNKNOWN CONFIGURATION |
| Generic Name | GLUE,SURGICAL,ARTERIES |
| Product Code | MUQ |
| Date Received | 2020-01-22 |
| Model Number | BG UNK |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CRYOLIFE, INC. |
| Manufacturer Address | 1655 ROBERTS BLVD. NW KENNESAW GA 30144 US 30144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Other; 3. Required No Informationntervention | 2020-01-22 |