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 08/29/2017 |
Event Type
malfunction
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Manufacturer Narrative
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A good faith effort will be made to obtain the applicable information relevant to the report.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 distal end of the sheath was kinked which caused difficulty with steerability of the balloon catheter.The sheath was replaced with resolve, 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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Product event summary: the sheath was returned and analyzed.Visual inspection of the sheath showed the sheath was intact with no apparent issues.In conclusion, the sheath failed the return product inspection.The sheath failed to deflect due to pull wire detachment from the ring.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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