BOSTON SCIENTIFIC CORPORATION COYOTE ES; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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Model Number 24691 |
Device Problem
Failure to Advance (2524)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/04/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Device evaluated by mfr.: returned product consisted of a coyote es balloon catheter.The balloon was loosely folded.The outer shaft, inner shaft, balloon and tip were microscopically examined.There are numerous hypotube and shaft kinks.The tip is damaged.Microscopic examination revealed that the balloon has a 10mm longitudinal tear starting at the proximal balloon cone.Inspection of the remainder of the device presented no other damage or irregularities.
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Event Description
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Reportable based on device analysis completed on 18jan2019.It was reported crossing difficulties were encountered.The target lesion was located in a vessel below the knee.After crossing a guide wire, a 2mm x 20mm x 143cm coyote es balloon catheter was advanced for pre-dilatation but the device failed to cross the lesion.The procedure was completed with a non-bsc device.No patient complications were reported.However, returned device analysis revealed a longitudinal balloon tear.
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