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Model Number 4FC12 |
Device Problem
Kinked (1339)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/02/2018 |
Event Type
malfunction
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that during a cryo ablation procedure, the balloon catheter could not be connected.Additionally, the sheath was bent.The balloon catheter, sheath and mapping catheter were all replaced, and the case was completed with cryo.No patient complications have been reported as a result of this event.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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(b)(6) 2018, 14:04:33: new incoming information received that the sheath could not bend smoothly after screwing, and could not reach the maximum curvature, therefore, the sheath was replaced.Additionally, the balloon catheter could not be recognized.The electrical umbilical cable and auto connection box were both replaced, without resolve.The balloon catheter was then replaced with resolve.
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Search Alerts/Recalls
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