Patients date of birth unk.Patients weight unk.Patients ethnicity/race unk.Other relevant history unk.Device model number, lot number, catalog number, expiration date, udi unk.Device 510k number unk because model number unk.The device was discarded, thus no investigation could be completed.Device manufacture date unk because lot number unk.Cardiac perforation 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 a right ventricular (rv) and a right atrial (ra) lead due to non function.Spectranetics lead locking devices (llds) were inserted into each lead to provide traction, and the physician chose a spectranetics 12f glidelight laser sheath to begin the case.During attempt to extract the ra lead, the glidelight was lasing within the superior vena cava and the ra lead tip pulled free.A small pericardial effusion was detected via transesophageal echocardiography (tee); an ra perforation was suspected.The effusion resolved without surgical intervention; however, a drain was placed to remove the blood from the pericardium.The physician chose not to remove the rv lead and did not attempt to unlock the lld before both were cut and capped and remained in the patient (mdr #1721279-2023-00050).The patient survived the procedure.This report captures the lld providing traction to the ra lead when a perforation occurred, requiring intervention.There was no alleged malfunction of any spectranetics devices in use during the procedure.
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