Catalog Number THA3032X150A-G |
Device Problem
Insufficient Information (3190)
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Patient Problem
Insufficient Information (4580)
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Event Date 10/03/2023 |
Event Type
Injury
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Event Description
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The clinician noticed that the grafts was pulsing blood at the anastomosis of the stent and surgical graft.He says that it appears to be coming from the green suture line that connects the stent, graft and skirt.He chose to leave the patient open' overnight to see if it would resolve on its own and it did.He was concerned with the bleeding as he never had this occur before with this device.He has implants 6-7 thoraflex so far and has not experienced this.The clinician reporting this occurrence to see if this can be investigated to see if a root cause can be identified and corrected.
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Manufacturer Narrative
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Clinical code: 4580 - insufficient information: additional information has been requested from site.Impact code: 4648- insufficient information: additional information has been requested from site.Medical device problem: 3190- insufficient information: additional information has been requested from site.Component code: 4755 -part/component/sub-assembly term not applicable.Type of investigation: 4110- trend analysis: a 5-year review of similar complaints (leakage blood oozing) gave an occurrence rate of 0.051% (complaints v sales).An increasing trend has been identified at this time, capa impact assessment 221 is currently ongoing.3331- analysis of production records: a review of manufacturing and qc records confirmed that there were no issues with the manufacture of the device.4114- device not returned: device remains implanted.4111- communication/interviews: additional information has been requested from site.
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Manufacturer Narrative
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Clinical code: clinical code: 4580 - insufficient information: additional information from site conformed the patient required open chest due to excessive bleeding from the suture line with packing of the mediastinum and return to or 24 hours later for definitive chest closure.Impact code: 4648- insufficient information: additional information from site conformed the patient required open chest due to excessive bleeding from the suture line with packing of the mediastinum and return to or 24 hours later for definitive chest closure.Medical device problem: 3190- insufficient information: additional information was received on 22 nov 23 from site that confirmed the graft was not pre-soaked prior to use.In the thoraflex hybrid us ifu (301-213-usen) it states to soak the graft for 5 minutes on approximately 700ml of saline solution.Component code: 4755 -part/component/sub-assembly term not applicable.Type of investigation: 4110- trend analysis: (b)(4).An increasing trend has been identified at this time, capa impact assessment 221 is currently ongoing.3331- analysis of production records: a review of manufacturing and qc records confirmed that there were no issues with the manufacture of the device.4114- device not returned: device remains implanted.4111- communication/interviews: additional information was received on 22 nov 23 from site that confirmed the graft was not pre-soaked prior to use.In the thoraflex hybrid us ifu (301-213-usen) it states to soak the graft for 5 minutes on approximately 700ml of saline solution.Investigation findings: 115-maintenance problem identified: : additional information was received on 22 nov 23 from site that confirmed the graft was not pre-soaked prior to use.In the thoraflex hybrid us ifu (301-213-usen) it states to soak the graft for 5 minutes on approximately 700ml of saline solution.Investigation conclusion: 18- failure to follow instructions: additional information was received on 22 nov 23 from site that confirmed the graft was not pre-soaked prior to use.In the thoraflex hybrid us ifu (301-213-usen) it states to soak the graft for 5 minutes on approximately 700ml of saline solution.
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Event Description
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The clinician noticed that the grafts was pulsing blood at the anastomosis of the stent and surgical graft.He says that it appears to be coming from the green suture line that connects the stent, graft and skirt.He chose to leave the patient [?]open' overnight to see if it would resolve on its own and it did.He was concerned with the bleeding as he never had this occur before with this device.He has implants 6-7 thoraflex so far and has not experienced this.The clinician reporting this occurrence to see if this can be investigated to see if a root cause can be identified and corrected.Additional information was received on 22 nov 23 from site that confirmed the graft was not pre-soaked prior to use.In the thoraflex hybrid us ifu (301-213-usen) it state [?]s to soak the graft for 5 minutes on approximately 700ml of saline solution this report is being submitted as final for mfg report #9612515-2023-00028 to provide event closure information for comp (b)(4).
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Search Alerts/Recalls
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