Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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The following was reported to gore: on (b)(6) 2024, the patient underwent placement of a gore® acuseal vascular graft (acusesl device) in an unknown anatomical location for dialysis access.It was reported that on (b)(6) 2024, the acuseal device was accessed for dialysis.The patient experienced a lot of bleeding and bruising.The physician performed an ultrasound on (b)(6) 2024 and observed delamination within the acuseal device.The patient will be brought back for a revision.
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H6 code c20: a review of the manufacturing records for the device could not be conducted because the serial/lot number remains unknown.Without a lot number or device serial number, the manufacturing date and/or production details cannot be determined, and the information provided to gore cannot be connected to a specific device.Cause of the reported event cannot be established based on evaluation of the information reported to gore.Further information regarding this event was requested by gore, but no further information has been reported, therefore this investigation is considered complete.H6 removed code c21 and added code c20 under investigation findings.H6 removed code d16 and added code d15 under investigation conclusions.
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