BIOSENSE WEBSTER INC AVAIL¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
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Catalog Number F6QRD010RT |
Device Problem
Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/18/2024 |
Event Type
malfunction
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Manufacturer Narrative
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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 ref.#(b)(4).
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Event Description
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It was reported that a patient underwent a supraventricular tachycardia (svt) ablation procedure with an avail¿ electrophysiology catheter and the shaft material was broken.It was reported that during the operation, the appearance of the fixed bend is damaged.The second catheter was used to complete the operation.The physician didn¿t use it in patient and switched another new one to complete the operation.There was no report on adverse event on patient.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.
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Manufacturer Narrative
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On (b)(6) 2024, the bwi product analysis lab received the complaint device for evaluation.The product analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
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Manufacturer Narrative
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It was reported that a patient underwent a supraventricular tachycardia (svt) ablation procedure with an avail¿ electrophysiology catheter and the shaft material was broken.It was reported that during the operation, the appearance of the fixed bend is damaged.The second catheter was used to complete the operation.The physician didn¿t use it in patient and switched another new one to complete the operation.There was no report on adverse event on patient.Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.A visual inspection evaluation of the returned device was performed following bwi procedures.Visual analysis of the returned sample revealed a broken superficial mark in the shaft area with no wires exposed.No other damage or anomalies were detected during the product analysis.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The damage observed in the shaft could be related to the catheter broken issue reported by the customer; therefore, the customer complaint was confirmed.The potential cause of the broken mark could not be determined, it could be related to the handling of the device during the procedure; however, this cannot be conclusively determined.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 ref.# (b)(4).
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