Model Number 87069 |
Device Problem
Electrical /Electronic Property Problem (1198)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/19/2022 |
Event Type
malfunction
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Event Description
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It was reported that during a procedure using an intellanav st catheter the power could not be increased during ablation.They attempted to increase the power by 5-10w, however, they could not increase it.They exchanged the catheter, and the issue was resolved.The procedure was then completed with no patient complications.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; therefore, a failure analysis of the complaint device could not be completed.If there is any further relevant information obtained, a supplemental medwatch will be filed.
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Event Description
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It was reported that during a procedure using an intellanav st catheter the power could not be increased during ablation.They attempted to increase the power by 5-10w, however, they could not increase it.They exchanged the catheter, and the issue was resolved.The procedure was then completed with no patient complications.The catheter has been 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 abnormalities were found.Next, they functionally tested the catheter's steering mechanisms and found the tension control knob and steering knob functioned properly in all configurations.Then, they tested the circuitry of the catheter via continuity testing where no shorts or open circuits were found.Finally, they tested the device's ability to deliver radio frequency (rf) energy for ablation purposes, and when connected to a known good rf generator the device was able to perform test ablations that were within the specifications.Based on all the available evidence the conclusion is that no problem was detected with the returned device, the reported allegation could not be replicated, and no other issues were found with the device.The allegation of an electrical issue, the inability to provide enough energy to complete ablation, was not confirmed by analysis.
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Search Alerts/Recalls
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