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 Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/03/2021 |
Event Type
malfunction
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Event Description
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It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified vessel below the knee.A 1.5mm x 20mm x 143cm coyote es balloon catheter was advanced for dilatation.However, during initial inflation at 10 atmospheres, the balloon ruptured.The device was removed from the patient's body without any problem and pinhole on the balloon was noted.The procedure was completed with another of the same device.No patient complications were reported and the patient condition was good.
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Event Description
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It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified vessel below the knee.A 1.5mm x 20mm x 143cm coyote es balloon catheter was advanced for dilatation.However, during initial inflation at 10 atmospheres, the balloon ruptured.The device was removed from the patient's body without any problem and pinhole on the balloon was noted.The procedure was completed with another of same device.No patient complications were reported and the patient status was good.
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Manufacturer Narrative
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Device evaluated by mfr.: returned product consisted of a coyote es 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 1.4cm from the tip.Inspection of the remainder of the device presented no other damage or irregularities.
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Search Alerts/Recalls
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