It was reported that a patient underwent an ablation procedure with a qdot micro catheter and a rupture of the insulating material issue occurred.Presence of blood at the end of the ablation catheter, like a rupture of the insulating material.Flush non-conforming before insertion in the patient.It was unknown if the procedure was delayed due to the reported event.It was also unknown if the procedure was successfully completed.There was no patient consequence.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.The event was assessed as mdr reportable for a rupture of the insulating material.
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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.A manufacturing record evaluation was performed for the finished device 31055913l number, and no internal actions related to the complaint was found during the review.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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