MAUDE Adverse Event Report: CRYOLIFE, INC. PHOTOFIX DECELLULARIZED BOVINE PERICARDIUM; INTRACARDIAC PATCH OR PLEDGET, BIOLOGICALLY DERIVED

Model Number	PFP0.8X8
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/26/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Upper middle aged male with history of carotid artery stenosis, hypertension and peripheral vascular disease.When the surgeon went to use the cryolife, photofix decellularized bovine pericardium patch, he was unable to identify rough side from the smooth side.Therefore, unable to use for procedure.

• Brand Name: PHOTOFIX DECELLULARIZED BOVINE PERICARDIUM
• Common Device Name: INTRACARDIAC PATCH OR PLEDGET, BIOLOGICALLY DERIVED
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd nw; kennesaw GA 30144
• MDR Report Key: 9817827
• Report Number: 9817827
• Device Sequence Number: 19604739
• Product Code: PSQ
• UDI-Device Identifier: 00877234000553
• UDI-Public: (01)00877234000553(17)211126(10)31120519
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/27/2020
• Report Date (Section F): 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PFP0.8X8
• Device Catalogue Number: PFP0.8X8
• Device Lot Number: 31120519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2020
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/11/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 63
• Date Report Sent to FDA: 02/27/2020