Model Number HGK1608 |
Device Problem
Material Frayed (1262)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/16/2022 |
Event Type
malfunction
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Event Description
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It was reported to intervascular that in an emergency setting, the vascular surgeon was preparing a hemagard knitted bifurcation graft by cutting it to size when she noticed fraying of the fabric.She decided to not use the graft and switch to a gelsoft plus bifurcation graft by terumo aortic.Complaint#: (b)(4).
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Manufacturer Narrative
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(4109/213) the review of historical data indicated that no other similar complaint was reported for the same sterilization lot number: 22d21.(3331/3233) the device history records review is pending.(11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.
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Event Description
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(b)(4).
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Manufacturer Narrative
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(4111) additional information was received from the distributor.It was indicated that the graft is available for analysis and metzenbaum dissecting scissors were used to cut the graft.(3331/213) the device history records review concluded that there was no non-conformance/planned deviation in relation with the event reported.(10/3233) it was reported that the product is available, it should be returned to intervascular for analysis.(11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.
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Event Description
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Complaint#: (b)(4).
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Manufacturer Narrative
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(10/213) the involved device was returned to intervascular and inspected by the quality assurance manager.As part of the visual inspection, the involved product was tested by cutting it.No fraying was observed.Based on the testing performed on the returned product, it was concluded that the frayed appearance is probably due to the instrument used to cut the graft or to the cutting technique.(61) the investigation concluded that the cause of the event is probably due to the instrument used to cut the graft or to the cutting technique.Please note that as per current product instructions for use, in the section "directions for use" it is indicated to use sharp surgical scissors to trim the intergard/ hemagard knitted vascular grafts.
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Search Alerts/Recalls
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