Model Number 24699 |
Device Problem
Material Rupture (1546)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/27/2019 |
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.A 3.0mm x 220mm x 150cm coyote balloon catheter was advanced for dilation.However, during inflation, the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications nor injuries reported.
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Manufacturer Narrative
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(b)(6).Returned product consisted of a coyote balloon catheter.Microscopic examination revealed a scratch in midshaft and pinhole.Microscopic examination of the balloon presented no irregularities in the balloon material or the ro marker that could have contributed to the damage.The pinhole in the midshaft prevented successful inflation of the device.
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Event Description
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It was reported that balloon rupture occurred.A 3.0mm x 220mm x 150cm coyote balloon catheter was advanced for dilation.However, during inflation, the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications nor injuries reported.
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Search Alerts/Recalls
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