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 11/22/2019 |
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.Vascular access was obtained via the femoral artery utilizing contralateral approach.The chronic totally occluded target was located in the moderately tortuous and moderately calcified right common and superficial fermoral artery.After crossing with various non-bsc guide wires and a non-bsc micro catheter, a 2mm x 20mm x 143cm coyote es balloon catheter was advanced for dilatation.However, during first inflation at 6 atmospheres, the balloon ruptured.The device was replaced with a new balloon of the same size and another balloon of a bigger size.A non-bsc stent was then deployed and the procedure was completed.No patient complications were reported.
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Event Description
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It was reported that balloon rupture occurred.Vascular access was obtained via the femoral artery utilizing contralateral approach.The chronic totally occluded target was located in the moderately tortuous and moderately calcified right common and superficial fermoral artery.After crossing with various non-bsc guide wires and a non-bsc micro catheter, a 2mm x 20mm x 143cm coyote es balloon catheter was advanced for dilatation.However, during first inflation at 6 atmospheres, the balloon ruptured.The device was replaced with a new balloon of the same size and another balloon of a bigger size.A non-bsc stent was then deployed and the procedure was completed.No patient complications were reported.
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Manufacturer Narrative
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(b)(6).Device evaluated by mfr.:returned product consisted of a coyote es balloon catheter.Microscopic inspection revealed that the tip was damaged.The inner shaft was buckled in the balloon and there was a pinhole in the middle of the balloon.There was no other damage or irregularities.
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