Common name: instruments, surgical, cardiovascular.Product code: dws.Concomitant devices: cook liberator beacon tip locking stylet, evolution shortie 9 fr, and byrd dilator sheath 8.5fr, 10fr, 11.5fr.Pma/510(k): class i (exempt).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available or upon completion of investigation.
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It was reported that the physician made lead control in the right atrial lead with liberator, one-tie, and evolution shortie 9 french.Access for procedure was gained from the left subclavian vein.After the tip of the lead was removed, lead extraction was attempted using a snare (other manufacturer) with a femoral approach.After grasping the tip of the lead with the snare, the physician confirmed that the lead coming out of the upper limb and the portion held by the snare were pull-through, without adhesions in the middle.However, the patient's side (distal end of the one-tie) should have been cut off, but the surgeon's side (proximal end of the one-tie) was cut off instead.As a result, the lead with the one-tie attached was pulled into the femoral region by the snare.Another physician who was at the side of the lower extremity inserted a 16fr sheath from the inguinal region.The 16fr sheath was removed and the thickened lead with attached one-tie was unable to pass through the puncture site and became stuck.The physician tried unsuccessfully to introduce the one-tie into cook's byrd dilator sheath via the inguinal lead, therefore the transvenous approach was abandoned.A vascular surgeon ultimately had to make an incision and remove the lead where the one-tie was attached.
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