A lead extraction procedure commenced to remove a left ventricular (lv) lead due to non function.A right ventricular (rv) and a right atrial (ra) lead were present in the patient, but were not initially targeted for extraction.A spectranetics lld e lead locking device (lld e) was inserted into the lv lead to provide traction.Beginning with a spectranetics 11f tightrail sub-c rotating dilator sheath, the lead began to break and progress stalled.The decision was then made to attempt removal of the rv lead, and an lld #2 was inserted into the rv lead for traction.The tightrail sub-c and a tightrail (long) were used to alternate between leads, along with a cook medical bulldog lead extender for additional traction.Stalled progress occurred after slight advancement on the rv lead, and efforts switched back to the lv lead.Advancement could not be achieved due to lead on lead binding on the lv lead.Therefore, the ra lead was targeted for extraction as well.An lld #2 was inserted into the ra lead for traction, but lead removal was unsuccessful.Slight increased bleeding was noted from the pocket (likely from enlargement of the subclavian vein access site with repeated insertions of the tightrail devices), but no perforation occurred.The surgeon placed a stitch in the vein to reduce the size of the hole (procedural complication, not device related).At that time, the lead extraction was aborted.No attempts were made to unlock the llds from the leads, so the rv lead/lld #2.Ra lead/lld #2 (mdr #3007284006-2024-00080) and lv lead/lld e (mdr #3007284006-2024-00081) were cut and capped, and remained in the patient.Plans were being made to remove the leads at a later date, and add a new system on the patient's right side.The patient survived the procedure.This report captures the lld #2 in the rv lead which was cut and capped and remained in the patient.There was no alleged malfunction of any spectranetics devices in use during the procedure.
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Patient's ethnicity/race unk a portion of the device was discarded, and a portion remained within the patient, thus no investigation could be completed.Although lld cut/cap is a known risk of complication with use of the lld, the physician did not attempt to unlock the lld from the rv lead prior to cutting and capping.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.
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