BOSTON SCIENTIFIC CORPORATION INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
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Model Number 87035 |
Device Problem
Improper Flow or Infusion (2954)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/13/2022 |
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 radiofrequency ablation procedure, an intellamap orion was selected for use.The irrigation of the catheter was blocked.When the pressure bag line was connected to the catheter, it did not start to flow.Trying to flush the orion with a syringe also was not possible.Exchanging the catheter resolved the issue, and the procedure was completed successfully.The device was disposed.
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