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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 05/23/2022 |
Event Type
Injury
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Manufacturer Narrative
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This case was reviewed and investigated according to the manufacturer¿s policy.Device: not applicable for this device.The visions pv.018 catheter was not returned for evaluation, thus no returned product investigation was performed.Do not apply to this submission.
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Event Description
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It was reported that during a therapeutic peripheral procedure, the visions pv.018 catheter distal tip separated while it was being retracted from the external left common iliac artery.The separated tip was removed with a snare and the procedure was completed with a non-manufacturer balloon-expandable stent system.The patient tolerated the procedure well with no patient injury reported.The patient was transferred to pacu for monitoring.This adverse event and product problem is being submitted due to the tip separation requiring intervention (snare).
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Manufacturer Narrative
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Block a4: patient weight available.Block a5: patient ethnicity and race available.Block d10: guide wire brand name available.Block g3: additional information was received on 18 july 2022; however, it was inadvertently missed in the supplemental 1 mdr submitted on 09 august 2022.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 b6 & b7: patient information received.Block h3: the visions pv.018 was returned without the distal portion of the device.The distal portion includes the distal tip, distal fillet, and scanner body.The overall device measures 142 cm, which confirms 3.3 cm was not returned.The portion of the device that was returned measures at 138.7 cm.Visual inspection found a hole on the expanded single lumen measuring approximately 0.04 square mm.Block h6: the probable cause of the observed failure is damage during use/handling.Strain, impact, and forces associated with use can affect the integrity of the 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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