MAUDE Adverse Event Report: CRYOLIFE, INC. BIOGLUE SURGICAL ADHESIVE; GLUE, SURGICAL, ARTERIES

Model Number BG3510-5-J

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hepatitis (1897)

Event Type  Injury  

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.

Event Description

According to the initial report "several cases have been reported where patients were (b)(6) after bioglue was used.".

Event Description

According to the initial report, "this is to inform you we have received several cases where patients were hcv false-positive after bioglue was used.These events are not limited to one hospital this time.We have just reached out for more information including the total number of patients." additional information received relayed originally three hospitals had reported the hcv false-positive but now one confirmed hospital to have 6 reported cases/patients, and another hospital confirmed to have no such reported case related to bioglue.The third hospital has given no response.A clinical study was not performed on these reported cases.Non-bioglue patients were not looked at as a control group.It is unknown what specific assay test was used by the investigators to determine that anti-bsa antibody caused a false reaction in the hcv assay.Nucleic acid confirmatory tests were not used to confirm that the positive hcv ab tests were in fact false positives.It is unknown if one instrument was used that produced all the false-positive hcvs or if other instruments were used.It is unknown how the investigator ruled out other sources of cross-reactive antibody from blood transfusions and other implants.

Manufacturer Narrative

There is no clear allegation of deficiency with how the bioglue performed in these patients or a resultant adverse event caused by the device.Bioglue is a terminally sterilized product that would not be a source of hcv transmission.The hcv false-positive results could be a result of many potential factors including the specificity of the assay test kits used and/or the calibration of the instrument(s) used to read the tests.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.

• Brand Name: BIOGLUE SURGICAL ADHESIVE
• Type of Device: GLUE, SURGICAL, ARTERIES
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd. nw; kennesaw GA 30144
• MDR Report Key: 8570664
• MDR Text Key: 143743530
• Report Number: 1063481-2019-00025
• Device Sequence Number: 1
• Product Code: MUQ
• Combination Product (y/n): N
• PMA/PMN Number: P010003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Type of Report: Initial,Followup
• Report Date: 06/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: BG3510-5-J
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/24/2019
• Initial Date FDA Received: 05/01/2019
• Supplement Dates Manufacturer Received: 04/24/2019
• Supplement Dates FDA Received: 06/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization