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Catalog Number PCF050250130 |
Device Problems
Difficult to Remove (1528); Device Dislodged or Dislocated (2923)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/02/2015 |
Event Type
malfunction
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Manufacturer Narrative
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Results: operational problem - the root cause is related to the direction of the folding pleats which appear not to be folded parallel to the shaft of the device.Once inside the artery, the folding pleats most likely encounter resistance related to a tight lesion, resulting an incomplete balloon expansion.Conclusion: operational context caused or contributed to event - the root cause is related to the direction of the folding pleats which appear not to be folded parallel to the shaft of the device.Once inside the artery, the folding pleats most likely encounter resistance related to a tight lesion, resulting an incomplete balloon expansion (b)(4).Event date approximate.
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Event Description
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Physician was attempting to treat a cto lesion in sfa recanalization.The physician proceeded with sub intimal technique to dilate the artery with one pacific xtreme device, length 300 and then with another pacific xtreme length 250, but with both devices, the physician was not able to perfectly dilate the lesion due to balloon twisting.The physician also had difficulty in retrieving both balloon into the is.The procedure was completed by stenting the artery.The devices were inspected prior to use and no issues were noted with the devices during preparation.No excessive force was used during the procedure.No patient injury or other sequelae were reported for this event.
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Manufacturer Narrative
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Cine image review the images provided for the evaluation shows that both the balloons were not able to inflate properly at the first inflation; there is a clear portion that is not expanded and evidence of necking in the balloon.
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Search Alerts/Recalls
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