Model Number 1973-03 |
Device Problem
Defective Device (2588)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/03/2023 |
Event Type
malfunction
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Event Description
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It was reported that the balloon length was shorter than expected.This ranger global dcb otw 6.0 x 60mm, 135cm was selected for use in a percutaneous angioplasty procedure.The lesion was in the superior femoral artery (sfa), was mildly calcified, had moderate tortuosity, and was 95 percent stenosed.During fluoroscopy during the procedure, it was suspected that the balloon length was 5.5cm instead of the expected 6cm.After the procedure the balloon length was measured outside the body and was 5.5cm.There was no patient injury.The device is expected to be returned.
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Manufacturer Narrative
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Device eval by manufacturer: upon receipt at our post market quality assurance laboratory, this ranger global dcb otw 6.0 x 60mm, 135cm was visually and microscopically examined.The outer shaft, inner shaft, balloon, and tip revealed no damages.Dimensional testing was performed by measuring the balloon from the proximal cone to the distal cone.The device measured within specifications.Inspection of the remainder of the device presented no damage or irregularities.Product analysis was unable to confirm the reported incorrect length.
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Event Description
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It was reported that the balloon length was shorter than expected.This ranger global dcb otw 6.0 x 60mm, 135cm was selected for use in a percutaneous angioplasty procedure.The lesion was in the superior femoral artery (sfa), was mildly calcified, had moderate tortuosity, and was 95 percent stenosed.During fluoroscopy during the procedure, it was suspected that the balloon length was 5.5cm instead of the expected 6cm.After the procedure the balloon length was measured outside the body and was 5.5cm.There was no patient injury.The device is expected to be returned.
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Search Alerts/Recalls
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