H3): the device was discarded, thus no investigation could be completed.H6): cardiac perforation is a known risk of complication with use of the lld.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 atrial (ra) and a right ventricular (rv) lead due to cied system/pocket infection.Spectranetics lld ez lead locking devices (lld ezs) were inserted into each lead to provide traction.Beginning with a spectranetics 12f glidelight laser sheath and then upsizing to a 14f glidelight on the ra lead, the lead was removed.Working on the rv lead next, the patient's blood pressure dropped and a pericardial effusion was detected via transesophageal echocardiography (tee).Rescue efforts began, including a pericardiocentesis (unsuccessful due to being tapped in the incorrect location), and sternotomy.A perforation to the ra was discovered and repaired.The rv lead was removed post-sternotomy, and the patient survived the procedure.This report captures the lld ez providing traction within the ra lead when the perforation occurred, requiring intervention.There was no alleged malfunction of any spectranetics devices in use during the procedure.
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