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.
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The patient was undergoing a thrombectomy procedure using indigo pump max canister (canister).During the procedure, the hospital staff noticed that the canister was cracked and, therefore, the procedure was completed using a new canister.There was no report of an adverse effect to the patient.
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