BIOSENSE WEBSTER INC DECANAV ELECTROPHYSIOLOGY CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
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Model Number R7F282CT |
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 05/18/2023 |
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.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.Manufacturer's reference number: (b)(4).
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Event Description
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It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a decanav electrophysiology catheter and a bad/ no ecg all channels (bs and ic) issue occurred.It was reported that an error 7 ¿ current leakage error was displayed when the decanav catheter was plugged in.The patient interface unit was turned off for a few minutes and changed out the decanav catheter cable without resolution.The "current leakage error" was accompanied by a loss of all signal including ecg.The signal interference (noise/loss) was observed all ecg (bs + ic) channels.It was observed on both carto® and recording system.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.The decanav catheter was replaced, the issue was resolved, and the procedure was continued.No adverse patient consequence was reported.The current leakage error is not mdr reportable.This issue is highly detectable and requires adjusting system components to continue with the procedure.Devices may require reset or replacing but cannot be used on the patient.Patient safety is unaffected by this issue.The bad/no ecg all channels (bs and ic) is mdr reportable.
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Manufacturer Narrative
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It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a decanav electrophysiology catheter and a bad/ no ecg all channels (bs and ic) issue occurred.It was reported that an error 7 ¿ current leakage error was displayed wihen the decanav catheter was plugged in.The patient interface unit was turned off for a few minutes and changed out the decanav catheter cable without resolution.The "current leakage error" was accompanied by a loss of all signal including ecg.The signal interference (noise/loss) was observed all ecg (bs + ic) channels.It was observed on both carto® and recording system.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.The decanav catheter was replaced, the issue was resolved, and the procedure was continued.No adverse patient consequence was reported.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation on 19-jun-2023.Visual inspection, magnetic sensor functionality, and electrical test of the returned device were performed following bwi procedures.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 (mre) was performed for the finished device number lot 31007764m and no internal action related to the complaint were found during the review.Based on the completed mre, the manufactured date and expiration date have been provided.Therefore, fields d4.Expiration date and h4.Device manufacture date have been populated with appropriate information.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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