The investigation of the returned device ((b)(4)) was unable to confirm the complaint allegation of graft wall "leaking" and "thinner than usual" and the inner diameter of the graft met specifications for an ag630 product code.No additional complaints from this batch were reported to date.Batch record review was performed; the batch met all criteria, including pressure testing, sterility testing, and final visual inspection upon release.The patient status was reported as stable.The complaint issue will continue to be monitored within artegraft, inc.Quality systems, quality assurance trending.Should additional information become available, a follow-up report will be submitted.
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Artegraft inc.Received an email communication from an authorized distributor (who was present with the doctor during the procedure) that an artegraft (collagen vascular graft) was identified as leaking during the pre-implant pressure testing per the corresponding artegraft ifu.Upon follow up communications, the distributor stated that no hole was visible but rather it appeared that the graft wall was "leaking and thinner than usual".It was also stated that when compared side by side, either the graft inner diameter may have been larger, or another graft's inner diameter was "much smaller" than the size on the label (5 mm id).This graft was not implanted.Another artegraft (ag630 product code) was utilized to complete the procedure.The patient is reported to be in stable condition.
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