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 05/22/2020 |
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 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 dilation.However, on the initial inflation at 10 atmospheres for 6 seconds, the balloon ruptured.The device was completely removed and the procedure was completed with another of the same device.No patient complications were reported.
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Manufacturer Narrative
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E1 initial reporter city: (b)(6).Device evaluated by mfr.:returned product consisted of a coyote es balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks.There was contrast and blood in the inflation lumen.The balloon was loosely folded.Microscopic inspection revealed tip damage.There was a pinhole at the marker band.There was no marker band damage detected.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 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 dilation.However, on the initial inflation at 10 atmospheres for 6 seconds, the balloon ruptured.The device was completely removed and the procedure was completed with another of the same device.No patient complications were reported.
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Search Alerts/Recalls
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