The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.
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The patient was undergoing a thrombectomy procedure in the pulmonary artery using an indigo system aspiration catheter 8 (cat8).During the procedure, the physician made one pass with the cat8 inside a non-penumbra sheath.Upon removal of the cat8, the hospital staff noticed that the cat8 was stretched, kinked and crushed.There was no report of an adverse effect to the patient.
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