MAUDE Adverse Event Report: CRYOLIFE, INC. ¿ KENNESAW PHOTOFIX PATCH - 0.8CM X 8CM; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

Model Number PFP0.8X8

Device Problems Fluid/Blood Leak (1250); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/11/2021

Event Type  Injury  

Event Description

According to the initial report,"[surgeon] tried a photofix patch for the first time on a carotid procedure.He told me that he had to take the patient back for bleeding after the patient coughed real hard.He said he looked around and when he touched the patch it started bleeding.He commented that he thinks because the patch is more pliable than what he had used that he might have to just sew the sutures closer together for the photofix patch.This investigation will be relegated to pfp.8x8, lot number 31042219.Additional question were answered: to clarify, did the observed bleeding come through the spaces between the sutures? yes, when he pushed on the middle of the patch.This apparently is common practice to test suture line bleeding.He said he didn¿t do it but should have during the initial implantation.Approximately how far apart did the surgeon place the sutures? he estimated 5mm¿s but he should have done them every 3mm¿s.What exactly did the surgeon do to intervene? can you elaborate on ¿control bleeding¿? did he add more sutures or did he do something else? he did an additional running stitch in the area where it was bleeding.How is the patient doing post-operatively? he said patient is doing fine and went home the next day after procedure.Are operative notes available for us to review? no.No additional information forthcoming.

• Brand Name: PHOTOFIX PATCH - 0.8CM X 8CM
• Type of Device: PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
• Manufacturer (Section D): CRYOLIFE, INC. ¿ KENNESAW; 1655 roberts blvd. nw; kennesaw GA 30144
• Manufacturer (Section G): CRYOLIFE, INC. ¿ KENNESAW; 1655 roberts blvd. nw; kennesaw GA 30144
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd.; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 11647937
• MDR Text Key: 245925406
• Report Number: 1063481-2021-00015
• Device Sequence Number: 1
• Product Code: DXZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162506
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 04/14/2021
• Device Model Number: PFP0.8X8
• Device Lot Number: 31042219
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/14/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other