BOSTON SCIENTIFIC CORPORATION MAESTRO 4000 CONTROLLER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
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Model Number 86248 |
Device Problem
Device Displays Incorrect Message (2591)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/01/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
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Event Description
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During preparation, a maestro 4000 controller was selected for use.It was reported that maestro system failed after self test.The software was reloaded several times, however, the issue persisted.The procedure was cancelled and was not completed.It is unknown whether the patient was sedated at time of procedure cancellation.No patient injury was reported.
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Search Alerts/Recalls
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