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.This report is associated with mfr report numbers: 3005168196-2017-01656.
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The patient was undergoing a thrombectomy procedure using an indigo system aspiration catheter 8 (cat8) and an indigo system separator 8 (sep8).During the procedure, the physician removed the cat8 and sep8 from the patient's body to place a balloon in the patient's vein.The hospital technician then accidentally dropped the cat8 on the floor and therefore, the cat8 was not used to complete the procedure.Additionally, a portion of the sep8 touched the trash and therefore, the sep8 was not used to complete the procedure.The procedure was completed using a new cat8 and a new sep8.There was no report of an adverse effect to the patient.
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