A4): patient''s weight unk.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 ventricular (rv) lead due to non function; ct confirmed that the lead tip was positioned outside the rv wall.A spectranetics lld #2 lead locking device (lld #2) was inserted into the lead to provide traction.Beginning with a spectranetics 16f glidelight laser sheath, progress was made through the vasculature to the right atrium (ra), and the lead released.Upon removal from the patient, a large amount of calcified fatty tissue was observed on the distal tip.The patient''s blood pressure slowly dropped and a pericardial effusion was detected via transesophageal echocardiography (tee).Rescue efforts began and a pericardiocentesis was performed.The effusion got smaller but did not resolve; therefore, a sternotomy was performed.An rv perforation was discovered and repaired.The patient survived the procedure.This report captures the lld #2 providing traction within the rv 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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