BIOSENSE WEBSTER INC WEBSTER¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, ELECTRODE RECORDING
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Model Number D6DR005RT |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/06/2022 |
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.Manufacturer's reference number: (b)(4).
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Event Description
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It was reported that a patient underwent a cardiac ablation procedure with a webster¿ electrophysiology catheter and a broken tip issue occurred.When the catheter was opened the doctor checked it and saw the point was fractured, therefore, it was changed it for a new one.Surgery was not delayed due to the reported event.It is unknown if procedure was successfully completed and if fragments were generated.There were no patient consequences.The broken tip issue is mdr reportable.
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Manufacturer Narrative
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Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Section h3.Has been updated.A manufacturing record evaluation (mre) was performed for the finished device and no internal action related to the complaint was found during the review.Additionally, the manufactured date has been provided.Therefore, field h4.Device manufacture date has been populated.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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