BIOSENSE WEBSTER INC NGEN RF GENERATOR, JAPAN; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
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Catalog Number D138404 |
Device Problem
Insufficient Heating (1287)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/21/2023 |
Event Type
malfunction
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Manufacturer Narrative
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E1.Initial reporter phone: (b)(6).Note: per fda request, mdr submissions for the ngen rf generator are to be reported with pma details of the catheter used along with the ngen rf generator.The hardware investigation has begun but it has not been 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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Event Description
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It was reported that a patient underwent an ablation procedure with a ngen rf generator, japan configuration and a temperature issue with ablation occurred.During ablation, the temperature of the qdot micro catheter did not rise and the temperature on the bulls eye usually rose and turned red after 3-5 seconds of ablation, but this time the behavior was different from usual, and the bulls eye remained blue.There was no error number.The catheter was used as it was.No other generator was used.The procedure was completed without patient's consequence.Additional information was received on (b)(6) 2023.The temperature and impedance values were not noted.Power noted was 50w.The generator displayed less than generator lower cut off value prior to the start of ablation and ablation was able to be conducted.Unable to identify the root cause.No replacement was conducted and the procedure was completed remaining the issue unresolved.Repair was not required.
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Manufacturer Narrative
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It was reported that a patient underwent an ablation procedure with a ngen rf generator, japan configuration.During ablation, the temperature of the qdot micro catheter did not rise and the temperature on the bulls eye usually rose and turned red after 3-5 seconds of ablation, but this time the behavior was different from usual, and the bulls eye remained blue.There was no error number.The catheter was used as it was.No other generator was used.The procedure was completed without patient's consequence.Additional information was received.The generator displayed less than generator lower cut off value prior to the start of ablation and ablation was able to be conducted.The investigation was completed on 01-feb-2024.The service was declined.No further investigation could be performed, as it was not initially required.A device history record evaluation was performed for the finished device number, and no internal actions related to the reported complaint condition were identified.All devices are manufactured, inspected, and released to approved specifications as part of biosense webster's quality process.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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