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Model Number 518-019 |
Device Problem
Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/07/2023 |
Event Type
Injury
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Manufacturer Narrative
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Patient's date of birth unk.Patient's weight unk.Other relevant history unk.Device lot number, expiration date unk.The device was discarded, thus no investigation could be completed.Device manufacture date unk because lot number unk.Although device damage is a known risk of complication with use of the lld, the cause for the lld breaking could not be established.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 ventricular (rv) lead due to malfunction.Functioning right atrial (ra) and left ventricular (lv) leads were present in the patient as well, not targeted for extraction.A spectranetics lead locking device (lld) was inserted into the rv lead to provide traction.Multiple spectranetics devices (13f tightrail guardian motorized dilator sheath, 16f glidelight laser sheath, and 13f tightrail rotating dilator sheath (long)) were used during the procedure.While the 13f tightrail long was being used and while significant traction was being applied, the rv lead and lld separated.The physician then removed the rv lead/lld remnants through the femoral vein using a snare.The procedure was completed with no reported patient harm.This event captures the lld which separated along with the rv lead, requiring intervention.
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Search Alerts/Recalls
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