BIOSENSE WEBSTER INC NGEN RF GENERATOR, US; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
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Catalog Number D138402 |
Device Problem
Mechanical Jam (2983)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/18/2023 |
Event Type
malfunction
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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 ngen rf generator, us and a stuck foot pedal occurred.When the medical team was pacing for phrenic stimulation through the ablation catheter, they were using a qdot catheter and when coming on ablation and received an error 2: "pedal stuck" message on the ngen generator.The system stopped ablating.Once the pedal stuck error cleared and the pedal was pressed again, the system ablated.There was no rmt or robotic system in the room.No patient consequences were reported.The stuck foot pedal is mdr-reportable.
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Manufacturer Narrative
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The hardware investigation has begun but it has not been completed at this time.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 18-sep-2023, the product investigation was completed.It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a ngen rf generator, us and a stuck foot pedal occurred.When the medical team was pacing for phrenic stimulation through the ablation catheter, they were using a qdot catheter and when coming on ablation and received an error 2: "pedal stuck" message on the ngen generator.The system stopped ablating.Once the pedal stuck error cleared and the pedal was pressed again, the system ablated.There was no rmt or robotic system in the room.No patient consequences were reported.Device evaluation details: the customer did not request service for the device.Bwi reached out and asked if service was needed, and service was declined.A device history record evaluation was performed for the finished device number (b)(6), and no internal actions related to the reported 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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