MAUDE Adverse Event Report: CRYOLIFE, INC. PHOTOFIX PATCH - 6CM X 8CM; INTRACARDIAC PATCH OR PLEDGET, BIOLOGICALLY DERIVED

Model Number	PFP 6X
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/25/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Cryolife sales representative relayed that photofix was explanted from the patient on (b)(6) 2021.The photofix was explanted due to it pulling away from the suture line at the valve.Attempts to obtain additional information have gone unmet.
Event or Problem Description
Cryolife sales representative relayed that photofix was explanted from the patient on (b)(6) 2021.The photofix was explanted due to it pulling away from the suture line at the valve.Attempts to obtain additional information have gone unmet.

• Brand Name: PHOTOFIX PATCH - 6CM X 8CM
• Common Device Name: INTRACARDIAC PATCH OR PLEDGET, BIOLOGICALLY DERIVED
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd. nw; kennesaw GA 30144
• MDR Report Key: 12583083
• Report Number: 1063481-2021-00029
• Device Sequence Number: 19754803
• Product Code: PSQ
• UDI-Device Identifier: 00877234000621
• UDI-Public: 00877234000621
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K183635
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2021

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
• Operator of Device: No Information
• Device Expiration Date: 09/05/2022
• Device Model Number: PFP 6X
• Device Catalogue Number: PFP6X8
• Device Lot Number: 12091020
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/08/2021
• Supplement Date Received by Manufacturer: 09/08/2021
• Initial Report FDA Received Date: 10/06/2021
• Supplement Report FDA Received Date: 11/02/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 1 YR