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Model Number 86700 |
Device Problem
Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/02/2022 |
Event Type
malfunction
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Event Description
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It was reported that a visions pv.018 catheter was used in a therapeutic peripheral procedure.During removal, it was noticed that the distal tip broke off within the non-philips introducer sheath, but able to be removed along with a non-philips guide wire.X-ray confirmed nothing was left in patient.The procedure was completed with a new device.The patient was discharged as expected, with no patient injury reported.This product problem is being submitted because the distal tip separated.There is a potential for harm if the malfunction were to recur.
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Manufacturer Narrative
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This complaint was reviewed and investigated according to the manufacturer¿s policy.The visions pv.018 catheter was discarded and not returned for evaluation, 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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Search Alerts/Recalls
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