CRYOLIFE, INC. ¿ KENNESAW PHOTOFIX PATCH - 0.8CM X 8CM; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
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Model Number PFP0.8X8 |
Device Problems
Fluid/Blood Leak (1250); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 03/11/2021 |
Event Type
Injury
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Event Description
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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.
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