MAUDE Adverse Event Report: CRYOLIFE, INC. ¿ KENNESAW BIOGLUE - UNKNOWN CONFIGURATION; GLUE,SURGICAL,ARTERIES

Model Number BG UNK

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

Patient Problems Pseudoaneurysm (2605); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

A publication, by passage, et al, ¿bioglue surgical adhesive¿an appraisal of its indications in cardiac surgery¿ ann thorac surg 2002;74:432¿7.Retrospective review of 115 consecutive patients in whom bioglue was used.Reoperation rate of 12% (14 patients) ¿ only 1 patient had bleeding from a site where bioglue was applied.

• Brand Name: BIOGLUE - UNKNOWN CONFIGURATION
• Type of Device: GLUE,SURGICAL,ARTERIES
• Manufacturer (Section D): CRYOLIFE, INC. ¿ KENNESAW; 1655 roberts blvd. nw; kennesaw GA 30144
• Manufacturer (Section G): CRYOLIFE, INC. ¿ KENNESAW; 1655 roberts blvd. nw; kennesaw GA 30144
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 12822333
• MDR Text Key: 282397652
• Report Number: 1063481-2021-00038
• Device Sequence Number: 1
• Product Code: MUQ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P010003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/17/2021

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 Model Number: BG UNK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/25/2021
• Initial Date FDA Received: 11/16/2021
• Supplement Dates Manufacturer Received: 10/25/2021
• Supplement Dates FDA Received: 12/17/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other