BOSTON SCIENTIFIC CORPORATION INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
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Model Number 87035 |
Device Problems
Activation, Positioning or Separation Problem (2906); Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/01/2024 |
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 catheter presented an undeployment failure.During an ablation procedure to treat an atrial fibrillation (afib), an intellamap orion high resolution mapping catheter was selected for use.After constructing the anatomy of the left atrium, the orion catheter was removed from the patient.There were complaints of difficulty opening and closing the splines.The tip of the catheter was bent by the doctor, who concluded that it was damaged.The orion catheter was no longer necessary for the procedure to proceed.The procedure was completed successfully without any patient complications.Catheter is expected to be returned for further analysis.
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Search Alerts/Recalls
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