Patient''s weight unk.Device model number, lot number, catalog number, expiration date and udi unk.Device 510k number unk because model number unk.A portion of the device was discarded and a portion remained in the patient, thus no investigation could be completed.Device manufacture date unk because lot number unk.Lld cut and cap is a known risk of complication with use of the lld device.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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A lead extraction procedure commenced to remove failed right atrial (ra) and externalized right ventricular (rv) leads.Present within the patient were two other leads: a left ventricular (lv) lead, externalized but functioning normally, and a functional rv lead.The patient was pacemaker dependent; in addition, the patient''s subclavian vein was occluded where the failed rv lead had externalized.Given the age of the patient (32 years old) and the dwell time of the leads (16 years), it was planned that the 2 failed leads would be extracted as a priority and the other two would be considered for removal, dependent on case progression and complexity.Spectranetics lead locking devices (llds) were inserted into the failed ra and rv leads to provide traction.The physician used a spectranetics 16f glidelight laser sheath on the rv lead, anticipating lead snowplow (lead bunching up), as well as getting over the externalization.Advancement was made to the innominate vein, where progress stalled due to lead on lead binding.Physician switched to attempt extraction of the ra lead with the glidelight, and made progress past the innominate vein to the superior vena cava (svc)/ra junction, where another binding site was encountered.The physician then removed the glidelight to again attempt removal of the rv lead, when the patient''s blood pressure dropped.A cardiac tamponade was confirmed via trans-oralesophageal echocardiography (toe).Rescue efforts began, including rescue balloon, bypass, and sternotomy.A 1-2 cm svc/ra junction perforation was discovered, along with a 1-2 cm innominate perforation (mdr #1721279-2022-00199) and repairs were successful.The ra lead (mdr #1721279-2022-00200) and rv lead were not removed; the physician attempted to unlock the llds from the leads but was unsuccessful so the llds within the leads were cut and capped and remained in the patient.No leads were removed during this event; epicardial leads were implanted and the patient was taken to recovery in stable condition, surviving the procedure.This report captures the lld present in the rv lead which was cut and capped and remained in the patient.
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