Model Number 4FC12 |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/26/2016 |
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 cryoablation procedure, the stopcock tubing had separated on the sheath.The sheath was replaced and the procedure 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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The flexcath advance sheath was returned and analyzed.Visual inspection of the sheath showed the stopcock distal end luer was completely detached from proximal end of the side port tube.In conclusion, the sheath failed the returned product inspection due to the stopcock detached from the side port tube.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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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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