VOLCANO CORPORATION VISIONS PV .035 DIGITAL IVUS CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR
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Model Number 88901 |
Device Problem
Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/24/2023 |
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.Blocks a2-a5: no information available.Blocks b6 & b7: no information available.Block c: not applicable for this device.Blocks d6 & d7: not applicable for this device.H6: the visions pv.035 catheter was not returned for evaluation, thus no returned product investigation was performed.H9: do not apply to this submission.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.035 catheter was used in a therapeutic peripheral procedure in a severely calcified proximal iliac vessel.During advancement to the lesion, approximately 6 mm of the distal tip separated inside the introducer sheath.The separated portion was suctioned successfully using a syringe.The procedure was completed with a new visions catheter.No patient injury reported.This adverse event and product problem is being submitted due to the tip separation, requiring intervention.
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Manufacturer Narrative
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Block h3: the visions pv.035 catheter was returned in three pieces.The distal tip separated approx.5.5 mm from the proximal tip, which aligns with the reported complaint of approx.6 mm.Additionally, the scanner body separated from the distal shaft, that likely occurred post-procedure since this was not reported by the facility.Both separated portions on the distal and proximal tip were slightly flattened near the breaking point.No missing material was observed.Block h6: the probable cause of the separated distal tip is damage during use/handling as evidence by the flattened section observed near the breaking point.Manipulation, 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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