MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2019-04-09 for BIOGLUE SYRINGE 5-PACK, 10 ML, JAPAN BG3510-5-J manufactured by Cryolife, Inc..
[141389043]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[141389044]
According to the initial report, "on (b)(6) 2018 first surgery): total arch replacement + mvp bioglue was applied to proximal and distal suture line. On (b)(6) 2019 (second surgery): descending aorta replacement as originally planned bioglue was applied to proximal suture line as a repeated use to the single patient. After aortic cross-clamp removal, both face and hand of the patient turned red and swollen in 3 min. Blood pressure did not rise (30mmhg) and the surgeon confirmed anaphylactic shock. Blocked, adrenaline, and steroid were administered. Patient was back at extracorporeal circulation and in 40 mins, cutaneous symptoms seemed to have recovered, but not blood pressure. Pcps (percutaneous cardiopulmonary support was used and patient was sent to icu. Later patient developed cerebral infarction due to circulation management and resulted in blindness'.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2019-00017 |
| MDR Report Key | 8497400 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2019-04-09 |
| Date of Report | 2019-07-23 |
| Date of Event | 2019-01-29 |
| Date Facility Aware | 2019-03-11 |
| Date Mfgr Received | 2019-03-11 |
| Date Added to Maude | 2019-04-09 |
| 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 SYRINGE 5-PACK, 10 ML, JAPAN |
| Generic Name | GLUE,SURGICAL,ARTERIES |
| Product Code | MUQ |
| Date Received | 2019-04-09 |
| Model Number | BG3510-5-J |
| 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 | 2019-04-09 |