SPECTRANETICS CORPORATION TIGHTRAIL ROTATING DILATOR SHEATH; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
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Model Number 545-513 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Great Vessel Perforation (2152); Cardiac Perforation (2513)
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Event Date 11/10/2023 |
Event Type
Injury
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Event Description
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A lead extraction procedure commenced to remove a right atrial (ra), a right ventricular (rv), and a left ventricular (lv) lead due to infection.Spectranetics lead locking devices (llds) were inserted into each lead to provide traction.The ra and lv leads were removed successfully without any issues.Then, using a spectranetics 14f glidelight laser sheath to remove the rv lead, the helix of the lead did not come back after use of lasing and traction.Devices switched to a spectranetics 13f tightrail rotating dilator sheath; and although progress was being made, the lead had not completely freed when the patient''s blood pressure dropped.Rescue efforts began immediately, including bypass and sternotomy.A perforation of the inferior vena cava (ivc)/ra junction was discovered and repaired.The rv lead was removed completely post-sternotomy, and the patient survived the procedure.This report captures the 13f tightrail in use when the perforation occurred, requiring intervention.There was no alleged malfunction of any spectranetics devices in use during the procedure.
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Manufacturer Narrative
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D4): device lot, expiration date unk.Partial udi populated.H3): the device was discarded, thus no investigation could be completed.H4): device manufacture date unk because lot number unk.H6): great vessel perforation and cardiac perforation are known risks of complication with use of the tightrail device.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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Search Alerts/Recalls
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