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Model Number 518-062 |
Device Problem
Break (1069)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 03/25/2024 |
Event Type
Injury
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Manufacturer Narrative
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Patient's weight unk a portion of the device was discarded, and a portion remained in the patient, thus no investigation could be completed.Lld cut and cap 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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Event Description
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A lead extraction procedure commenced to remove a right atrial (ra) and a right ventricular (rv) lead due to non function.Spectranetics lld ez lead locking devices (lld ezs) were inserted into each lead to provide traction.Beginning with a spectranetics 12f glidelight laser sheath and a spectranetics visisheath dilator sheath, the ra lead was removed.Working to remove the rv lead with the same glidelight and visisheath, the lead would not release and the distal tip began to stretch.At this time, further attempts to remove the rv lead were abandoned.An attempt was made to unlock the lld ez from the rv lead, but was unsuccessful; therefore, the rv lead/lld were cut and capped and remained in the patient.The patient survived the procedure.This report captures the lld ez within the rv lead which was cut and capped and remained in the patient.
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Search Alerts/Recalls
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