Model Number 87069 |
Device Problem
Defective Device (2588)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/11/2022 |
Event Type
malfunction
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Event Description
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It was reported that during an supraventricular velocity(svt) ablation procedure to treat atrial fibrillation using an intellanav st catheter, the rf power did not increase and was unable to reach the desired temperature output upon attempt to deliver ablation energy.The catheter was exchanged with another of same device.And the procedure was completed.No patient complications were reported.The catheter is expected to be returned for analysis.
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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 an supraventricular velocity (svt) ablation procedure to treat atrial fibrillation using an intellanav st catheter, the rf power did not increase and was unable to reach the desired temperature output upon attempt to deliver ablation energy.The catheter was exchanged with another of same device.And the procedure was completed.No patient complications were reported.The catheter is expected to be returned for analysis.
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Manufacturer Narrative
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Upon receipt at boston scientific's post market laboratory the catheter was first visually inspected and no defects were noted.Next they tested the catheter's functional mechanisms by testing the steering knob and tension control knob.Both knobs worked as expected and no abnormal resistances were felt.Next the electrical and magnetic functionality was tested, no open or shorts were detected, however, the magnetic field sensor resistances did not fall within specifications.They then dissected the catheter in order to determine the failure point of the magnetic sensor.The electrical opening was confirmed in the wires.Also the manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.With all available information the allegation was confirmed, as the electrical short could lead to the failure observed in the field.
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Search Alerts/Recalls
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