A lead extraction procedure commenced to remove a right atrial (ra) and a right ventricular (rv) lead due to non function and occlusion.First, it was reported that the ra lead was extracted without issue.Then, a spectranetics lld ez lead locking device (lld ez) was inserted into the rv to provide traction.While using a spectranetics 16f glidelight laser sheath and a spectranetics visisheath dilator sheath to remove the rv lead, the lead tip freed.However, the patient''s blood pressure dropped, with a pericardial effusion detected and growing.Rescue efforts began, including rescue balloon and sternotomy.A small rv perforation was discovered and repaired, and the patient survived the procedure.This report captures the lld ez 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.
|
A4): patient''s weight unk.B7): other relevant history 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.
|