A4): patent's weight unk.B6): relevant tests/laboratory data 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.
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A lead extraction procedure commenced to remove a right ventricular (rv) lead due to non function.Prior to the procedure, it had been confirmed that the rv lead was perforated through the rv.A spectranetics lld ez lead locking device (lld ez) was inserted into the lead to provide traction.Using a spectranetics tightrail sub-c rotating dilator sheath, advancement was made approximately 2 inches into the subclavian vein when the rv lead came free and a pericardial effusion was detected.Rescue efforts began, including bypass and sternotomy.A perforation in the rv was discovered and repaired, and the patient survived the procedure.This report captures the lld ez providing traction to the rv lead when the perforation opened, requiring intervention.There was no alleged malfunction of any spectranetics devices in use during the procedure.
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