(b)(4).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.The hospital disposed of the device.
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The patient was undergoing a thrombectomy procedure using an indigo system aspiration catheter 6 (cat6).During preparation for the procedure, the physician noticed the cat6 was pinched from the middle to the proximal end upon removal from the packaging; however, the physician decided to attempt using the damaged cat6.The cat6 was unable to aspirate thrombus due to being kinked and crimped down mid to proximal shaft and therefore it was removed.The procedure was completed using a new cat6.There was no report of an adverse effect on the patient.
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