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 07/06/2016 |
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 cryo ablation procedure, while hand injecting contrast dye through the sheath, the stopcock became detached.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 device 4fc12 with lot 98402, was returned and analyzed.Visual inspection of the device showed the stopcock distal end luer was completely detached from the side port tube proximal end.Visual inspection also showed the device was not used.In conclusion, the reported issue was confirmed through testing.The device 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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