BOSTON SCIENTIFIC CORPORATION MAESTRO 4000 POD, 150W; GENERATOR, LESION, RADIO FREQUENCY
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Model Number 86374 |
Device Problems
Material Integrity Problem (2978); Output below Specifications (3004)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/14/2022 |
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 during a procedure using a maestro 4000 pod, 150w the ablation catheter was unable to reach the desired power.They exchanged the pod, however, there was no information provided on the patient's outcome or if the procedure was completed.It is unknown if the pod is available to be returned.
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Search Alerts/Recalls
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