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Model Number 1177-01 |
Device Problem
Inflation Problem (1310)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/06/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Device eval by mfr: the returned product consisted of a ranger drug coated balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed no damages.Microscopic examination revealed a pinhole in 131mm from the tip.Inspection of the remainder of the device presented no other damage or irregularities.
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Event Description
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Reportable on analysis completed on 07dec2023.It was reported that the balloon was unable to inflate.A ranger drug-coated balloon was selected for use in the superficial femoral artery (sfa).The target lesion was sfa 80% stenosed with calcification.Inflation was attempted but the balloon could not inflate.The device was exchanged for a new device, same model.The procedure was completed.There were no patient complications.However, device analysis revealed a pinhole.
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Search Alerts/Recalls
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