During preparation for a thrombectomy procedure, the physician was unable to track two penumbra system separators 3d (sep3ds) through a penumbra system 3max reperfusion catheter (3maxc) on the back table and subsequently, the sep3ds became kinked.The sep3ds became kinked prior to use and therefore, were not used in the procedure.The procedure was completed using a new sep3d and a velocity delivery microcatheter (velocity).
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Please note that although the device was initially reported as available for return, additional information provided indicated that the device was no longer available fore return; therefore, the report has been updated accordingly.The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report numbers: 3005168196-2018-00028; 3005168196-2018-00434.
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