Model Number 3851 |
Device Problems
Difficult to Remove (1528); Device Dislodged or Dislocated (2923)
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Patient Problems
Perforation of Vessels (2135); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/26/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Age at time of event- 18 years or older.Initial reporter address 1: (b)(6).
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Event Description
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It was reported that the blade penetrated in the lesion.The 75% stenosed target lesion was located in the moderately tortuous and severely calcified left coronary artery.A 10mmx3.00mm wolverine coronary cutting balloon was selected for use.During the procedure, dilation was performed twice and was deflated.However, the device got caught and penetrated in the lesion upon retrieval.It was then eventually retrieved but the blade was damaged; partially lifted.The procedure was completed with a different device.No further patient complications reported.
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Event Description
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It was reported that the blade penetrated in the lesion.The 75% stenosed target lesion was located in the moderately tortuous and severely calcified left coronary artery.A 10mmx3.00mm wolverine coronary cutting balloon was selected for use.During the procedure, dilation was performed twice and was deflated.However, the device got caught and penetrated in the lesion upon retrieval.It was then eventually retrieved but the blade was damaged; partially lifted.The procedure was completed with a different device.No further patient complications reported.It was further reported that the physician met resistance when removing the device, but it was just still simply removed.There was no damage on the vessel.
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Manufacturer Narrative
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Updated lot number, initial reporter last name and device codes.Corrected patient codes.A2.Age at time of event- 18 years or older e1.Initial reporter address(b)(6).Device evaluated by manufacturer: the device was returned for analysis.A visual and microscopic examination identified that the balloon was returned in a deflated state.The balloon had been subjected to positive pressure and was partially inflated with contrast media.The following blade damage was noted on one blade: approximately 1.5mm of a blade segment was missing.The pad was intact with no damage noted.No damage was observed to the remaining blades and pads.A visual and tactile examination found no kinks present along the hypotube.A visual and tactile examination found no damage along the shaft polymer extrusion.No issues were noted with the tip of the device.A visual and microscopic examination found no issue with the marker bands.
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Search Alerts/Recalls
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