Model Number 87031 |
Device Problem
Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/25/2021 |
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 an ablation procedure involving a maestro 4000 generator and rhythmia mapping system connected via a maestro connection box.It was reported that the systems did not recognize the related intellanav ablation catheters.The settings for the maestro 4000 generator were resetting when the catheter was moved.After examination of the maestro connection box, a break on the cable to the rf generator was noted.The procedure was cancelled, however, no patient complications were reported.
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Manufacturer Narrative
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The device was returned to boston scientific for analysis.Visual inspection confirmed a loose cable jacket on the cable to the generator.
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Event Description
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During an ablation procedure involving a maestro 4000 generator and rhythmia mapping system connected via a maestro connection box.It was reported that the systems did not recognize the related intellanav ablation catheters.The settings for the maestro 4000 generator were resetting when the catheter was moved.After examination of the maestro connection box, a break on the cable to the rf generator was noted.The procedure was cancelled, however, no patient complications were reported.
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Search Alerts/Recalls
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