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

Model Number	PFP 6X8
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	Unspecified Heart Problem (4454)
Date of Event	09/08/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the initial report received via email on 06-oct-2021 from cryolife sales representative (csr), s.G., the surgeon told me that he's had multiple issues using photofix on aortic surgical cases.He mentioned one case in particular where he used pf to do a managuan root enlargement.He said that the patch never incorporated/remodeled.
Event or Problem Description
According to the initial report received via email on 06-oct-2021 from cryolife sales representative (csr), s.G., the surgeon told me that he's had multiple issues using photofix on aortic surgical cases.He mentioned one case in particular where he used pf to do a managuan root enlargement.He said that the patch never incorporated/remodeled.No additional information will be forthcoming.

• 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
• Manufacturer (Section G): CRYOLIFE, INC.; 1655 roberts blvd. nw; kennesaw GA 30144
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd. nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 12745392
• Report Number: 1063481-2021-00032
• Device Sequence Number: 17321962
• Product Code: PSQ
• UDI-Device Identifier: 00877234000621
• UDI-Public: 00877234000621
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 12/18/2021

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: PFP 6X8
• Device Catalogue Number: PFP6X8
• Device Lot Number: 11031621
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2021
• Supplement Date Received by Manufacturer: 10/05/2021
• Initial Report FDA Received Date: 11/03/2021
• Supplement Report FDA Received Date: 12/18/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown