The product was disposed of by the hospital and is no longer available for return.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.
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While preparing an indigo system aspiration catheter 8 (cat8) for a thrombectomy procedure, the hospital technologist inadvertently dropped the cat8 off the sterile field.The cat8 was dropped prior to use and therefore, was not used in the procedure.The procedure was completed using another cat8.
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