Model Number 39345-401510 |
Device Problems
Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/14/2023 |
Event Type
malfunction
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Event Description
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It was reported that blade was partially separated.The 95% stenosed target lesion was located in the mildly tortuous and moderately calcified left superficial femoral artery.A 4.0mm x 15mm wolverine peripheral cutting balloon was selected for use.During the procedure, the catheter was applied to several parts of the blood vessel.When the balloon was removed after inflation, it was noted that the blade was partially separated from the balloon.The balloon was able to be removed as usual and the blades were completely removed outside the body.The procedure was completed with a different device.No patient complications were reported.
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Manufacturer Narrative
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Device evaluated by mfr: the device was returned for evaluation.A visual examination of the returned device identified that the balloon had been inflated and was not refolded.It is not known when the balloon was subjected to positive pressure.The balloon of the device was visually examined, and no issues were noted.A visual examination of the returned device identified that 5mm blade were noted to have lifted on the proximal end of one of the blades.All other blades were present and fully bonded to the balloon surface.No issues were noted with the tip section of the device.A visual examination found no issue with the markerbands.A visual and tactile examination identified no kinks or damage to the shaft of the returned device.No other issues were identified during the product analysis.
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Event Description
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It was reported that blade was partially separated.The 95% stenosed target lesion was located in the mildly tortuous and moderately calcified left superficial femoral artery.A 4.0mm x 15mm wolverine peripheral cutting balloon was selected for use.During the procedure, the catheter was applied to several parts of the blood vessel.When the balloon was removed after inflation, it was noted that the blade was partially separated from the balloon.The balloon was able to be removed as usual and the blades were completely removed outside the body.The procedure was completed with a different device.No patient complications were reported.
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Search Alerts/Recalls
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