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Model Number 014R |
Device Problem
Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/30/2023 |
Event Type
Injury
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Manufacturer Narrative
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This complaint was reviewed and investigated according to the manufacturer¿s policy.Test/laboratory data & other relevant history: no information available.Implant date & explant date: not applicable for this device.The visions pv.014p rx 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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Event Description
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It was reported that a visions pv.014p rx catheter was used in a therapeutic peripheral procedure, in a moderately calcified distal sfa.During use, the catheter distal tip separated inside the patient and required removal with a snare.Fluoroscopy and x-ray confirmed no piece was retained inside the patient.The patient was discharged after post care with no injury reported.This adverse event and product problem is being submitted due to the tip separation requiring intervention (snare).
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Search Alerts/Recalls
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