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 12/16/2019 |
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 moderately calcified superficial femoral artery.A 1.5mm x 20mm x 143cm coyote es balloon catheter was advanced for dilatation; however, it ruptured upon inflation.The procedure was completed with another of the same device.No patient complications nor injuries were reported.
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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 moderately calcified superficial femoral artery.A 1.5mm x 20mm x 143cm coyote es balloon catheter was advanced for dilatation; however, it ruptured upon inflation.The procedure was completed with another of the same device.No patient complications nor injuries were reported.It was further reported that the balloon was initially inflated at 6 atmospheres for 5 seconds and during the second inflation at 6 atmospheres for 5 seconds, the balloon ruptured.
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Search Alerts/Recalls
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