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 2018-12-04 for BIOGLUE SURGICAL ADHESIVE UNKNOWN manufactured by Cryolife, Inc. ? Kennesaw.
[129174092]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[129174093]
Khidr, alaa mohamed, et al. "combined use of a fiberscope and fuji uniblocker for removal of retained bronchial tissue glue after repair of a disrupted left main bronchus. " sage journals (2018). A (b)(6) fell from a great height and had numerous injuries, "he suffered from diffuse axonal injury, a fracture of the second cervical spine vertebra, as well as fractures to both maxillary sinuses, and to the base of the skull. He also suffered from a left flail chest, bilateral 'hemopneumothoracies', and a disrupted lmsb. " he was in remarkable health before the fall per the article. The patient had surgery on the disrupted left main stem bronchus (lmsb) through a left thoracotomy. Bioglue was applied externally to seal the air leak from the anastomotic line. "bronchoscopic examination through the placed right double lumen endobronchial tube revealed a totally obliterated lmsb lumen, which required revision of the bronchial anastomosis with extraction of the previously dispensed bioglue. After the surgery, the patient was ventilated in the surgical intensive care unit. " the bedside bronchoscopic exam showed a patent lmsb, intact anastomotic suture line, and retained piece of polymerized bioglue in the right main bronchus (rmb). There was a need to extract the retained bioglue because of the "possibility of local hypersensitivity reaction such as swelling or edema, or tissue necrosis, infection, or mineralization. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2018-00048 |
| MDR Report Key | 8128423 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-12-04 |
| Date of Report | 2019-01-28 |
| Date Facility Aware | 2018-11-06 |
| Date Mfgr Received | 2018-11-06 |
| Date Added to Maude | 2018-12-04 |
| 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. 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 | 2018-12-04 |
| Model Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CRYOLIFE, INC. ? KENNESAW |
| Manufacturer Address | 1655 ROBERTS BLVD. NW KENNESAW GA 30144 US 30144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-12-04 |