Patient's weight unk the device was discarded, thus no investigation could be completed.In the spectranetics ifu, it warns to not abandon a lead in a patient with an lld still inside the lead; severe vessel or endocardial wall damage may result from the stiffened lead or from fracture or migration of the abandoned device.The physician did not attempt to unlock the lld from the ra lead prior to cutting and capping the lld/lead.There was no evidence of malfunction of the lld.
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A lead extraction procedure commenced to remove a right ventricular (rv) and a right atrial (ra) lead due to cied system/pocket infection.Spectranetics lead locking devices (llds) were inserted into each lead to provide traction.A spectranetics 16f glidelight laser sheath was calibrated and used in the patient for a few seconds.An area on the device was observed to be knotted/kinked (kink could have occurred during handling of the device during calibration).The device's laser fibers became apparent through that knotted/kinked area with just a few seconds of lasing (mdr #1721279-2021-00256).The device was discarded; another glidelight device was opened and used.However, after several attempts with different tools including snaring from the groin, the rv and ra leads, with llds present within each lead, were cut and capped and remained in the patient (mdr #1721279-2021-00257 lld in rv lead).The physician did not attempt to unlock the llds from the leads prior to cutting and capping.The patient survived the procedure.This report captures the lld which remained in the ra lead when it was cut/capped by the physician.There was no alleged malfunction of the llds used in the procedure.
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