Model Number 87047 |
Device Problem
Material Integrity Problem (2978)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/21/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
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Event Description
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It was reported that the irrigation tubing was broken.During the procedure a intell-anav mifi open-irrigated ablation catheter the irrigation tubing was broken.The catheter was exchanged, and the issue was resolved.The procedure was completed without any patient complications.
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Manufacturer Narrative
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Visual inspection noted that the irrigation tubing is torn at the proximal (narrowest) side of the adhesive joint securing the tubing to the luer fitting.Dried bodily fluids were found on the luer tubing and distal end of the device.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
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Event Description
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It was reported that the irrigation tubing was broken.During the procedure a intellanav mifi open-irrigated ablation catheter the irrigation tubing was broken.The catheter was exchanged and the issue was resolved.The procedure was completed without any patient complications.
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Search Alerts/Recalls
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