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 11/12/2018 |
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 with blood in the balloon and inflation lumen.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 pinhole at the distal markerband.The inner shaft is buckled in numerous locations.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 20-dec-2018.It was reported that crossing difficulties were encountered.The target lesion was located in the vessel below the knee.A 2mm x 20mm x 143cm coyote es balloon catheter was advanced for pre-dilatation.However, the device was unable to cross the lesion.The procedure was complete with a different device.No patient complications were reported.However, returned device analysis revealed balloon pinhole.
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