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

Model Number UNKNOWN

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems No Information (3190); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Multiple attempts to gain additional information have been requested without success.This investigation is currently ongoing.Any additional information will be provided in the follow-up report.

Event Description

According to initial report, the surgeon stated, "we experienced an adverse incident using bioglue with a cochlear implant recently.".

Manufacturer Narrative

Additional information from distributor was received, "[surgeon] says that a theatre sr.Said that he could use bioglue instead of tisseal in patient's ear.They borrowed product from neuro and used it on patient.Patient's eardrum was completely destroyed." multiple attempts to obtain additional information have been made with no response.A review of manufacturing records could not be performed as lot numbers are unknown.Additionally, a query could not be performed for potential lot numbers shipped to the hospital prior to implant as date of implant is unknown.A review of the available information was performed.There is no literature or data to support the use of bioglue during a cochlear implant.This is not an approved indication.Ifu [instructions for use] precautions state, ¿do not implant bioglue into closed anatomic locations that are in immediate proximity to nerve structures.¿ the inner ear is enclosed in bone and is in close proximity to neural structures.Using bioglue during a cochlear implant is inappropriate application of bioglue.Post production residual risk is communicated in the product's labeling and ifu.

Event Description

According to initial report, the surgeon stated "we experienced an adverse incident using bioglue with a cochlear implant recently.".

• 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: 7125363
• MDR Text Key: 95179111
• Report Number: 1063481-2017-00039
• 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: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 02/16/2018

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: Physician
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/21/2017
• Initial Date Manufacturer Received: 11/21/2017
• Initial Date FDA Received: 12/18/2017
• Supplement Dates Manufacturer Received: 11/21/2017
• Supplement Dates FDA Received: 02/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other