Model Number D132705 |
Device Problem
Signal Artifact/Noise (1036)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/12/2022 |
Event Type
malfunction
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Manufacturer Narrative
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If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
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Event Description
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It was reported that a patient underwent an ablation procedure with a thermocool® smart touch¿ bi-directional navigation catheter and there was a no ecg/ekg signal available for the physician to monitor the patient¿s heart rhythm.Initially it was reported that the connection of the thermocool® smart touch¿ bi-directional navigation catheter induced important artifact on all other signals (intracardiac and ecg), as well as on the anesthetist ecg.Disconnecting the catheter resolves the issue.There was no patient consequence reported.Multiple attempts had been made to obtain clarification to this complaint.However, no further information had been made available.With the information available, this event was assessed as not mdr reportable for a ¿bad/partial ecg (body surface and/or intracardiac)¿ issue as the risk to the patient was low.Additional information was received on 19-may-2022.There was no ecg/ekg signal available for the physician to monitor the patient¿s heart rhythm.During the signal interference/loss, the affected catheter was not inside the patient¿s body.There was no patient impact.Additional follow-up was made to confirm whether signal interference (noise/loss) was not observed on carto® and the recording system.The file will be re-reviewed if additional information is received at a later date.However, with the additional response stating that there was a no ecg/ekg signal available for the physician to monitor the patient¿s heart rhythm, the signal issue was reassessed to mdr reportable.Therefore, the awareness date for this mdr reportable issue is 19-may-2022.
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Manufacturer Narrative
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In the 3500a initial report it was reported that additional follow-up was made to confirm whether signal interference (noise/loss) was not observed on carto® and the recording system.A response was received on 21-jul-2022 stating that it was unknown about the noise.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
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Manufacturer Narrative
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The investigation was completed on 07-sep-2022.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device number 30629971m and no internal actions related to the complaint was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
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Search Alerts/Recalls
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