BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QDOT-MICRO, BI-DIRECTIONAL, F-J CURVE, C3, SPLIT HANDLE CATHETER

    MDR report key: 10363270 · Received August 4, 2020

    Report

    Report Number
    2029046-2020-00995
    Event Type
    Injury
    Date Received
    August 4, 2020
    Date of Event
    July 6, 2020
    Report Date
    July 6, 2020
    Manufacturer
    BIOSENSE WEBSTER INC.
    Product Code
    DRF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN REPORTED AS DISCARDED, THEREFORE NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 30271644L NUMBER, AND NO INTERNAL ACTION 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. THE ¿SUSPECTED MEDICAL DEVICE¿ REPORTED IN SECTION D OF THIS REPORT IS NOT MARKETED IN USA OR APPROVED BY THE FDA. HOWEVER, IT IS BEING REPORTED AS BIOSENSE WEBSTER CONSIDERS THIS AS A SIMILAR DEVICE TO THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER APPROVED UNDER P030031/S078. MANUFACTURER'S REF. #(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR PERSISTENT ATRIAL FIBRILLATION WITH A QDOT-MICRO, BI-DIRECTIONAL, F-J CURVE, C3, SPLIT HANDLE CATHETER AND SUFFERED CEREBROVASCULAR ACCIDENT (CVA) REQUIRING AN UNSPECIFIED INTERVENTION. POST-PROCEDURE, CVA WAS DISCOVERED BY COMPUTERIZED TOMOGRAPHY (CT) SCAN AT THE AWAKENING OF THE PATIENT. THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY SPECIALIZED IN FIBRINOLYSIS. AN UNSPECIFIED INTERVENTION (UNKNOWN IF MEDICAL OR SURGICAL) WAS PROVIDED. EXTENDED HOSPITALIZATION WAS REQUIRED AS A RESULT OF THE ADVERSE EVENT. PATIENT¿S OUTCOME IS UNKNOWN. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PROCEDURE RELATED AS AN ETHANOL INFUSION WAS USED IN THE MARSHALL¿S VEIN. NO BWI PRODUCT MALFUNCTIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825490 QDOT-MICRO, BI-DIRECTIONAL, F-J CURVE, C3, SPLIT HANDLE CATHETER SIMILAR DEVICE D134801, PMA # P030031/S078 DRF BIOSENSE WEBSTER INC. 30271644L

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R