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 Consequences Or Impact To Patient (2199)
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Event Date 11/19/2019 |
Event Type
malfunction
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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 severely tortuous and severely calcified superficial femoral artery.A 4mm x 20mm x 144cm coyote es balloon catheter was advanced for dilatation.However, during the second inflation at 8 atmospheres for 8 seconds, the balloon ruptured.The procedure was completed with a different device.No patient complications were reported.
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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 severely tortuous and severely calcified superficial femoral artery.A 4mm x 20mm x 144cm coyote es balloon catheter was advanced for dilatation.However, during the second inflation at 8 atmospheres for 8 seconds, the balloon ruptured.The procedure was completed with a different device.No patient complications were reported.
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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 longitudinally torn the length of the balloon.There were numerous kinks throughout the catheter.
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Search Alerts/Recalls
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