Additional information was obtained from the customer memo included with the returned product: the female patient, age 81, had a complete atrioventricular block (cavb).The catheter was placed until 12 dec 2021.The catheter was replaced since it became unable to pace.The chronology was as follows.09.17.2021 papillary muscle rupture of mitral valve and free wall rupture occurred due to acute myocardial infarction (ami).Mitral valve replacement (mvr) and hemostasis were performed.10.27.2021 a pacing catheter was inserted for the complete atrioventricular block (cavb).11.09.2021 the pacing catheter was replaced due to suspected infection.The catheter was inserted from the right subclavian vein.The tip of the catheter was found severely bent when the catheter was inserted.One bipolar pacing catheter with attached cap at gate valve was returned for evaluation.Clotted blood was observed from the catheter and inside the balloon.The reported issue of unable to pace was confirmed.Continuity testing confirmed a full open condition in the proximal circuit.The distal circuit was found to be continuous.A cut down of the catheter body was performed just proximal side of the proximal electrode to expose the pacing lead wires.Continuity testing confirmed a full open condition around catheter tip.It was also confirmed that the proximal circuit was continuous from just proximal side of the proximal electrode to proximal connector pin.As received, catheter tip was bent.The balloon inflated but failed to maintain its inflation due to leakage from a gap around circumference between proximal electrode and catheter body.Per ifu the incidence of complications increases significantly with in dwelling periods longer than 72 hours.No visible damage was observed from balloon and windings.Complaint histories for all reported events are reviewed against trending control limits monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.
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