Model Number D132705 |
Device Problems
Communication or Transmission Problem (2896); Electrical Shorting (2926)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/13/2023 |
Event Type
malfunction
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Event Description
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It was reported that a patient underwent a premature ventricular contraction (pvc) procedure during which (shortly after zeroing the catheter for force), the medical team experienced a current leakage error which affected all egms and ecg on both carto and recording system.The staff unplugged all cables from the front of the patient interface unit (piu) and then plugged in one by one.Upon connecting the ablation catheter cable, the current leakage error reappeared.The team decided to change cable and same issue.Scrub nurse did mention that the new cable did click into the catheter better than the previous cable.The medical team then rebooted carto, continued study and took a new ablation catheter with the second cable which resolved the issue.No patient consequences were reported.It was confirmed that no other ecg monitoring was available during the issue.Current leakage is not mdr-reportable.Bad/no ecg across all channels (bs and ic) is mdr-reportable.
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Manufacturer Narrative
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The bwi product analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc.Or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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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On 13-jul-2023, the product investigation was completed.It was reported that a patient underwent a premature ventricular contraction (pvc) procedure during which (shortly after zeroing the catheter for force), the medical team experienced a current leakage error which affected all egms and ecg on both carto and recording system.The staff unplugged all cables from the front of the patient interface unit (piu) and then plugged in one by one.Upon connecting the ablation catheter cable, the current leakage error reappeared.The team decided to change cable and same issue.Scrub nurse did mention that the new cable did click into the catheter better than the previous cable.The medical team then rebooted carto, continued study and took a new ablation catheter with the second cable which resolved the issue.No patient consequences were reported.Device evaluation details: visual analysis revealed no damage or anomalies on the device.A magnetic sensor functionality test was performed, and the device was visualized and recognized correctly; no magnetic issues or current leakage errors were observed.An electrical test was performed, and no electrical issues were found.A manufacturing record evaluation was performed for the finished device number 31008683m, and no internal action related to the complaint was found during the review.The issues reported by the customer could not be replicated during the product investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.The instructions for use contain the following recommendation: ecg noise is typically generated as the result of the improper connection of the body surface ecg patch to the patient.This noise is the most significant during ablation.To resolve this situation, verify the proper connection.It is recommended to turn off the notch filter for this verification.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.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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