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.H3 other text: placeholder.
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The patient was undergoing a thrombectomy procedure in the anterior tibial artery using an indigo system catrx aspiration catheter (catrx), a non-penumbra sheath, and a guidewire.During the procedure, the physician completed two passes using the catrx.While removing the catrx under aspiration for flushing, the physician noticed that the catrx was fractured.The proximal two thirds of the catrx was pulled out from the sheath without incident.While removing the distal end of the catrx from the patient using a snare device, the catrx fractured again.The physician was able to remove all fragments of the catrx from the patient and nothing remained in the patient.The procedure was completed using a long guide catheter, the same sheath, and manual aspiration.There was no report of an adverse effect to the patient.
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