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Model Number 206135061 |
Device Problem
Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/25/2022 |
Event Type
malfunction
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Event Description
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The tack endovascular system (tes) was used to treat the slightly tortuous and moderately calcified peripheral lesions.Four tacks were deployed successfully.During removal, it was noted that the distal portion of the inner core separated inside the introducer sheath.The introducer sheath was removed with the separated tes contained within the sheath.Imaging confirmed no piece was retained inside the body.The same introducer sheath was placed back inside the patient to complete the procedure.No patient injury reported.This product problem is being submitted due to the shaft separation.There is a potential for harm if the malfunction were to recur.
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Manufacturer Narrative
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Patient information regarding relevant tests/laboratory data is unknown.This information was not available from the facility.The tack device was infectious and discarded by the facility, thus no returned product investigation was performed.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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Manufacturer Narrative
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Blocks d1/ g1: manufacturer address was updated from 1285 drummers lane, suite 200, wayne, pa 19087 to 5905 nathan lane north, plymouth, mn 55442.This correction was made to align the address with the fda registration number.
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Manufacturer Narrative
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Blocks d1/ g1: manufacturer address was updated from 5905 nathan lane north, plymouth, mn 55442 to 1285 drummers lane, suite 200, wayne, pa 19087 to match the information on the product label.
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Search Alerts/Recalls
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