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Model Number 87042 |
Device Problems
Device Displays Incorrect Message (2591); Data Problem (3196)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/11/2022 |
Event Type
malfunction
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Event Description
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It was reported that during a rhythimia mapping procedure, the backpatch was not being recognized.The backpatch was changed out, but still got would not recognize.Two catheters, three cables, and the ablation pod were exchanged and also did not resolve the issue.The rhythimia signal station and workstation were rebooted, and the issue was temporally resolved, once ablation was started , the backpatch would disappear again.Physician cancelled case and was unable to complete the ablation.
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Manufacturer Narrative
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It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
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Manufacturer Narrative
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It was indicated that the device will not be returned for evaluation.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 rhythimia mapping procedure, the backpatch was not being recognized.The backpatch was changed out, but still got would not recognize.Two catheters, three cables, and the ablation pod were exchanged and also did not resolve the issue.The rhythimia signal station and workstation were rebooted, and the issue was temporally resolved, once ablation was started , the backpatch would disappear again.Physician cancelled case and was unable to complete the ablation.
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Event Description
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It was reported that during a rhythimia mapping procedure, the backpatch was not being recognized.The backpatch was changed out, but still got would not recognize.Two catheters, three cables, and the ablation pod were exchanged and also did not resolve the issue.The rhythimia signal station and workstation were rebooted, and the issue was temporally resolved, once ablation was started , the backpatch would disappear again.Physician cancelled case and was unable to complete the ablation.
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Manufacturer Narrative
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The device was returned to boston scientific for analysis.Visual inspection did not reveal any abnormalities.The device was connected to a test catheter and was able to perform a test ablation successfully with no complications.The device passed all relevant testing and inspection.
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Search Alerts/Recalls
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