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 right coronary artery (rca) using an indigo system catrx aspiration catheter (catrx).During the procedure, after attaching the catrx for aspiration, the physician noticed that the catrx would no longer aspirate.Therefore, the catrx was removed.The procedure was completed using a new catrx.There was no adverse effect to the patient.
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