Model Number 518-067 |
Device Problem
Crack (1135)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/04/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Patient date of birth unavailable.Patient weight unavailable.
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Event Description
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A lead extraction procedure commenced to remove a right ventricle lead due to infection.During the procedure, the physician was using a spectranetics tightrail rotating dilator sheath and a spectranetics lead locking device to extract the lead.While the physician was pulling the lead from the lld, it cracked between the distal loop and the proximal connector.The physician then used a cook medical needle's eye snare, by femoral access, to grab the lead from the distal end in order to free the lead and the tightrail.The tightrail was freed from the subclavian artery successfully and the lead was successfully extracted with the needle's eye snare through the femoral access.There was no injury to the patient.This report is being submitted due to the potential for serious injury with recurrence.
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Manufacturer Narrative
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The initial mdr 1721279-2020-00041 created for this event is being corrected.In section b5 it was first reported that the spectranetics tightrail device was "freed from the subclavian artery".This was inaccurate information; the tightrail device was instead freed from the subclavian vein.This report is being submitted to correct the mdr and to accurately reflect the location within the patient anatomy.H3 other text : placeholder.
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Event Description
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A lead extraction procedure commenced to remove a right ventricle lead due to infection.During the procedure, the physician was using a spectranetics tightrail rotating dilator sheath and a spectranetics lead locking device to extract the lead.While the physician was pulling the lead from the lld, it cracked between the distal loop and the proximal connector.The physician then used a cook medical needle's eye snare, by femoral access, to grab the lead from the distal end in order to free the lead and the tightrail.The tightrail was freed from the subclavian vein successfully and the lead was successfully extracted with the needle's eye snare through the femoral access.There was no injury to the patient.This report is being submitted due to the potential for serious injury with recurrence.
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Search Alerts/Recalls
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