Model Number 87047 |
Device Problems
Leak/Splash (1354); Device Displays Incorrect Message (2591)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/21/2020 |
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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During an ablation procedure a intellanav mifi open-irrigated was selected for use.The physician observed leaking around irrigation tubing that entered the handle of the catheter after experiencing a temperature error on the maestro generator.The catheter was exchanged and procedure was completed without any patient complications.
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Event Description
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During an ablation procedure a intellanav mifi open-irrigated was selected for use.The physician observed leaking around irrigation tubing that entered the handle of the catheter after experiencing a temperature error on the maestro generator.The catheter was exchanged and procedure was completed without any patient complications.
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Manufacturer Narrative
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Visual inspection noted the irrigation tubing is torn at the proximal (narrowest) side of the adhesive joint securing the tubing to the luer fitting.Dried body fluids were noted on the catheter shaft.There is no evidence this device was used in a manner inconsistent with the labeled indications.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
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Search Alerts/Recalls
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