BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 10931787 · Received December 2, 2020

    Report

    Report Number
    2029046-2020-01836
    Event Type
    Injury
    Date Received
    December 2, 2020
    Date of Event
    November 5, 2020
    Report Date
    November 5, 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 30355129L NUMBER, AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. 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. NOTE: THE ¿SUSPECTED MEDICAL DEVICE¿ 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 510(K)/PMA # P030031/S078. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A QDOT-MICRO, BI-DIRECTIONAL, D-F CURVE, C3, SPLIT HANDLE CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. AT THE END OF THE PROCEDURE THE PATIENT BECAME HYPOTENSIVE AND CARDIAC TAMPONADE WAS CONFIRMED BY ULTRASOUND. EPHEDRINE WAS INJECTED AND PERICARDIOCENTESIS WAS PERFORMED TO DRAIN 300ML OF FLUID FROM THE PERICARDIAL SPACE, RENDON WAS LEFT IN PLACE. THE PATIENT WAS INTUBATED AND AWAKE. PATIENT HAD FULLY RECOVERED FROM THE EVENT. PROLONGED HOSPITALIZATION WAS NOT REQUIRED. PHYSICIAN BELIEVED THE ISSUE OCCURRED DUE TO THE PATIENT¿S CONDITION DUE TO AN INFLAMMATORY RESPONSE WITH COMBINATION QMODE+ AND ELIQUIS TREATMENT NOT STOPPED BEFORE THE PROCEDURE. THE PHYSICIAN DID NOT RELATE THE CAUSALITY OF THE EVENT TO THE BWI PRODUCT. NO BWI PRODUCT MALFUNCTION NOR ERROR MESSAGES WERE REPORTED. THERE WERE NO SPECIFIC CRITERIA ON THE CARTO IN FAVOR OF A PROBLEM RELATED TO THE ABLATION. DESPITE THE PHYSICIAN DID NOT RELATE THE CAUSALITY OF THE ADVERSE EVENT TO THE BWI PRODUCT, THIS EVENT IS BEING CONSERVATIVELY REPORTED UNDER THE ABLATION CATHETER, GIVEN THE FACT THE TAMPONADE WAS CONFIRMED AT THE END OF THE PROCEDURE, WHICH SUGGESTS THAT RADIOFREQUENCY (RF) THERAPY WAS ALREADY APPLIED; THEREFORE, THE RELATIONSHIP BETWEEN THE ABLATION AND THE ADVERSE EVENT OCCURRENCE CANNOT BE EXCLUDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1398227 QDOT-MICRO, BI-DIRECTIONAL, D-F CURVE, C3, SPLIT HANDLE CATHETER SIMILAR DEVICE D134801, PMA # P030031/S078 DRF BIOSENSE WEBSTER INC. 30355129L

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R