Patient's date of birth unk.Patient's weight unk.Relevant tests/laboratory data unk.Other relevant history unk.A portion of the device was discarded and a portion remained in the patient, thus no investigation could be completed.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), a right ventricular (rv) and a left ventricular (lv) lead, extraction indication unk.Spectranetics lead locking devices (llds) were inserted into each lead to provide traction.The physician used multiple spectranetics devices to attempt extraction: a 13f tightrail sub-c rotating dilator sheath, an 11f tightrail rotating dilator sheath, and 12f and 14f glidelight laser sheaths.The physician could not extract the leads, so the decision was made to cut and cap the leads until an open extraction procedure could be scheduled.The physician attempted to unlock the llds from the leads but was unsuccessful.The rv lead (mdr #1721279-2022-00157), and lv lead (mdr #1721279-2022-00158), along with the llds within, were cut and capped and remained in the patient.There was no reported patient harm.This report captures the lld present in the ra lead which was cut and capped and remained in the patient.
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