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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CRYOLIFE, INC. PHOTOFIX UNKNOWN CONFIGURATION; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
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CRYOLIFE, INC. PHOTOFIX UNKNOWN CONFIGURATION; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE Back to Search Results
Model Number UNKNOWN
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Injury  
Manufacturer Narrative
Multiple attempts have been made to gain further information to no avail.No product information could be obtained; therefor, a manufacturer's review could not be completed.The available information has been reviewed and a definitive root cause is unknown.Although a root cause could not be identified, the report has been documented for trending purposes.Should any additional information be received the investigation will be reopened and additional reports will be sent.
 
Event Description
According to an email on (b)(6) 2018: "this was reported verbally today (b)(6) 2018) from the surgeon.Both cases happened in the previous 2 weeks, but had the same issue.Serial number was not recorded or passed on, but i will attempt to track it down in the next few days.[surgeon] reported that he had two patches 'tear' at the suture hole and that both cases happened the same way.Both patches were used in a femoral endartectomy where the surgeon had a calcified native femoral artery with lots of plaque present.He sutured normally using a 6.0 prolene and on the proximal segment, where the vessel was calcified, he bit into the patch, then through the calcified tissue and pulled tight.When he pulled the suture tight, the suture cut through the patch elongating the suture hole.It happened on 2-3 bites on the proximal end.This created large needle holes and bleeding.{surgeon] used remaining patch material to 'buttress' or 'pledgett' these needle holes to stop the bleeding.He reported that his bites were normally space and about 2 mm into the patch.He did not remove the original patch material and used remaining patch material to reinforce the suture line.It added approximately 20-25 minutes to each case.He also reported that when he pulled the suture tight, that it felt like it was getting snagged on plaque.He additionally commented that he had done nothing different than when he used the [competitor's] patch material and had never experienced this before.His last was concern was the potential of a pseudoaneurysm forming at the suture site." multiple attempts have been made to gather more information to no avail.A report has been sent for each reported event.
 
Event Description
According to an email on(b)(6) 2018, "this was reported verbally today (b)(6) 2018, from the surgeon.Both cases happened in the previous 2 weeks, but had the same issue.Serial number was not recorded or passed on, but i will attempt to track it down in the next few days.[surgeon] reported that he had two patches 'tear' at the suture hole and that both cases happened the same way.Both patches were used in a femoral endartectomy where the surgeon had a calcified native femoral artery with lots of plaque present.He sutured normally using a 6.0 prolene and on the proximal segment, where the vessel was calcified, he bit into the patch, then through the calcified tissue and pulled tight.When he pulled the suture tight, the suture cut through the patch elongating the suture hole.It happened on 2-3 bites on the proximal end.This created large needle holes and bleeding.{surgeon] used remaining patch material to 'buttress' or 'pledgett' these needle holes to stop the bleeding.He reported that his bites were normally space and about 2 mm into the patch.He did not remove the original patch material and used remaining patch material to reinforce the suture line.It added approximately 20-25 minutes to each case.He also reported that when he pulled the suture tight, that it felt like it was getting snagged on plaque.He additionally commented that he had done nothing different than when he used the [competitor's] patch material and had never experienced this before.His last was concern was the potential of a pseudoanureysm forming at the suture site." multiple attempts have been made to gather more information to no avail.A report has been sent for each reported event.
 
Manufacturer Narrative
Multiple attempts have been made to gain further information to no avail.No product information could be obtained; therefor, a manufacturer's review could not be completed.The available information has been reviewed and a definitive root cause is unknown.Although a root cause could not be identified, the report has been documented for trending purposes.The risk has been evaluated and each individual hazard is mitigated and reduced as low as possible by design and process.Post production residual risk is communicated in the product's labeling and ifu (instructions for use).Should any additional information be received the investigation will be reopened and additional reports will be sent.This report is being submitted as required by federal regulations and does not constitute an admission that the device caused or contributed to the reported event.Furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to cryolife is accurate or has been confirmed by cryolife.
 
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Brand Name
PHOTOFIX UNKNOWN CONFIGURATION
Type of Device
PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
Manufacturer (Section D)
CRYOLIFE, INC.
1655 roberts blvd. nw
kennesaw GA 30144
MDR Report Key8066281
MDR Text Key127061208
Report Number1063481-2018-00045
Device Sequence Number1
Product Code DXZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 01/14/2019
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 Operator Health Professional
Device Model NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/15/2018
Initial Date FDA Received11/13/2018
Supplement Dates Manufacturer Received10/15/2018
Supplement Dates FDA Received01/14/2019
Patient Sequence Number1
Patient Outcome(s) Other;
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