BOSTON SCIENTIFIC CORPORATION COYOTE ES; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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Model Number 24691 |
Device Problem
Material Rupture (1546)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/21/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).
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Event Description
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It was reported that balloon rupture occurred.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified vessel below the knee.A 2.5mm x 40mm x 146cm coyote es balloon catheter was advanced for dilation.However, on initial inflation at 14 atmospheres, the balloon ruptured.The device was completely removed and the procedure was completed with a different device.No patient complications were reported and patient status was good.
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Manufacturer Narrative
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(b)(6).Device evaluated by mfr.: the device was returned for analysis.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed no damages.Microscopic examination revealed a longitudinal tear in the balloon 34mm from the tip and is approximately 7mm long.Inspection of the remainder of the device presented no other damage or irregularities.
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Event Description
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It was reported that balloon rupture occurred.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified vessel below the knee.A 2.5mm x 40mm x 146cm coyote es balloon catheter was advanced for dilation.However, on initial inflation at 14 atmospheres, the balloon ruptured.The device was completely removed and the procedure was completed with a different device.No patient complications were reported and patient status was good.
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Search Alerts/Recalls
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