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Model Number 518-062 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 11/20/2023 |
Event Type
Injury
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Manufacturer Narrative
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A4): patient''s weight unk.A5a./5b.): patient''s ethnicity/race unk.B6): relevant tests/laboratory data unk.B7): other relevant history unk.H3): a portion of the device was discarded, and a portion remained in the patient, thus no investigation could be completed.H6): although lld cut/cap is a known risk of complication with use of the lld, the physician did not attempt to unlock the lld from the lead prior to cutting and capping.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 cied system/pocket infection.A spectranetics lld ez lead locking device (lld ez) was inserted into the lead to provide traction.Multiple spectranetics devices (glidelight laser sheath, tightrail rotating dilator sheath) were used in the procedure.During the case, the patient's blood pressure dropped (unknown origin) but no injury was identified, no surgical intervention was required, and the patient was treated with medications.At that time, the decision was made to abandon the procedure.The physician did not attempt to unlock the lld from the rv lead, so the rv lead/lld ez 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.There was no alleged malfunction of any spectranetics devices in use during the procedure.
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Search Alerts/Recalls
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