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U.S. Department of Health and Human Services

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

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CRYOLIFE, INC. BIOGLUE - UNKNOWN CONFIGURATION GLUE, SURGICAL, ARTERIES Back to Search Results
Model Number BG UNK
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Embolism (1829); Urinary Tract Infection (2120)
Event Type  Injury  
Manufacturer Narrative
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.
 
Event Description
According to the initial report received for journal article: ¿do renal tumor characteristics affect the number of hemostatic agents used during partial nephrectomy?¿ retrospective study of 71 patients who undergone partial nephrectomy (pn) surgery due to renal mass between january 2013 and february 2019. Each patient was administered one or more hemostatic agent (ha) during the procedure. Article mentions postoperative complications of urinary leakage, arteriovenous fistula, embolization, urinary tract infection. However they do not state whether these complications occurred to those 17 patients that bioglue was applied to.
 
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Brand NameBIOGLUE - UNKNOWN CONFIGURATION
Type of DeviceGLUE, SURGICAL, ARTERIES
Manufacturer (Section D)
CRYOLIFE, INC.
1655 roberts blvd. nw
kennesaw GA 30144
Manufacturer (Section G)
CRYOLIFE, INC.
1655 roberts blvd. nw
kennesaw GA 30144
Manufacturer Contact
rochelle maney
1655 roberts blvd
kennesaw, GA 30144
7704193355
MDR Report Key9375187
MDR Text Key168581011
Report Number1063481-2019-00072
Device Sequence Number1
Product Code MUQ
Combination Product (y/n)N
Reporter Country CodeTU
PMA/PMN Number
P010003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/26/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberBG UNK
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/20/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/26/2019 Patient Sequence Number: 1
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