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 09/26/2022 |
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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During a radiofrequency cardiac ablation a intellanav st was selected for use.The device discontinuous discharge and poor discharge.An exchange of the device resolved the problem.The procedure was completed without any patient complications.
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Event Description
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During a radiofrequency cardiac ablation a intellanav st was selected for use.The device discontinuous discharge and poor discharge.An exchange of the device resolved the problem.The procedure was completed without any patient complications.Furthermore, additional information clarified that when the physician stepped on the pedal, it was supposed to discharge constantly to ablate, but with this device, it would stopped automatically after a short while, and the physician had to step on the pedal again.The ablate could not be performed.Then the physician used another of same device and the issue no longer exist.
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Manufacturer Narrative
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Additional information: b5.
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Event Description
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During a radiofrequency cardiac ablation a intellanav st was selected for use.The device discontinuous discharge and poor discharge.An exchange of the device resolved the problem.The procedure was completed without any patient complications.Furthermore, additional information clarified that when the physician stepped on the pedal, it was supposed to discharge constantly to ablate, but with this device, it would stopped automatically after a short while, and the physician had to step on the pedal again.The ablate could not be performed.Then the physician used another of same device and the issue no longer exist.
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Manufacturer Narrative
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Upon receipt at boston scientific's post market laboratory the catheter was visually inspected, and the device does not have any visual defects.The functional testing revealed the steering knob and the tension control knob functioned properly on both lock and unlock positions.No abnormal resistance was felt when actuating the steering mechanism.The continuity test was performed, and the device was found within specifications.No open or shorts were detected.The radio frequency ablation test was found to be within specifications.With all available information the complaint could not be confirmed as the reported failure was not able to be reproduced and the device presented with no issues.
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Search Alerts/Recalls
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