Model Number 39345-401510 |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/29/2024 |
Event Type
malfunction
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Event Description
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It was reported that the blade was partially lifted.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.A 4.0mm x 15mm wolverine peripheral cutting balloon was selected for use.During the procedure, it was noted that the blade got caught in the calcification when it was removed after inflation.Furthermore, part of the blade was lifted up.The device was completely removed from the patient's body and the procedure was complete.No patient complications and the patient was good post procedure.
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Manufacturer Narrative
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Device evaluated by mfr.: the device was returned for analysis.A visual examination of the returned device identified that the balloon had been inflated.The device was attached to an encore inflation unit and filled the balloon with liquid to facilitate an inspection of the blades.The balloon of the device was visually examined, and no issues were noted.A visual examination was performed on the returned device.It was noted that approximately 5mm of the proximal end of one blade had lifted distally from the balloon material.The remaining 15mm of the blade remained fully bonded to the balloon material.The damage identified is consistent with excessive force being applied when resistance is encountered during the withdrawal of the device through the sheath.All other blades were intact and fully bonded to the balloon material.A visual examination identified damage to the tip of the device.This type of damage is consistent with excessive force being applied when resistance is encountered when crossing a lesion.A visual examination found the guidewire lumen to have accordion damage between the distal markerband and the tip.This type of damage is consistent with rapid withdrawal of the device from the guidewire.A visual and tactile examination found the hypotube to be kinked at more than one location.This type of damage is consistent with excessive force being applied to the device.
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Event Description
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It was reported that the blade was partially lifted.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.A 4.0mm x 15mm wolverine peripheral cutting balloon was selected for use.During the procedure, it was noted that the blade got caught in the calcification when it was removed after inflation.Furthermore, part of the blade was lifted up.The device was completely removed from the patient's body and the procedure was complete.No patient complications and the patient was good post procedure.
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Search Alerts/Recalls
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