BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QDOT MICRO¿ CATHETER

    MDR report key: 21902893 · Received April 24, 2025

    Report

    Report Number
    2029046-2025-01313
    Event Type
    Injury
    Date Received
    April 24, 2025
    Date of Event
    March 27, 2025
    Report Date
    June 4, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAE
    UDI-DI
    10846835017076
    PMA / PMN Number
    P210027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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).

    Additional Manufacturer Narrative · 0

    ON 14-MAY-2025, THE BWI PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE PRODUCT INVESTIGATION WAS SUBSEQUENTLY COMPLETED. IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION CARDIAC ABLATION WITH A QDOT MICRO¿ CATHETER, AND THE PATIENT EXPERIENCED PERICARDIAL EFFUSION WITH PRESSURE TREATED WITH PERICARDIOCENTESIS. THE INFORMATION INDICATED THAT DURING THE CASE, A PERICARDIAL EFFUSION OCCURRED, AND A SPIKE IN FORCE WHILE THEY WERE ABLATING. THEY NOTICED THAT THE PATIENT¿S BLOOD PRESSURE HAD DROPPED, AND PERICARDIAL EFFUSION CONFIRMED ON ICE (INTRACARDIAC ECHOCARDIOGRAPHY). A PERICARDIOCENTESIS WAS PERFORMED ON THE PATIENT. THE PATIENT LAST KNOWN STATUS WAS RECOVERING IN THE (ICU) INTENSIVE CARE UNIT AND POTENTIALLY WILL BE RELEASED THE DAY OF OR THE NEXT. IT WAS LATER CONFIRMED THAT THE PATIENT DID NOT UNDERGO EXTENDED/PROLONGED HOSPITALIZATION. DEVICE EVALUATION DETAILS: THE PRODUCT WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION. A VISUAL INSPECTION AND REVISION OF ALL FEATURES WERE PERFORMED FOLLOWING J&J MEDTECH PROCEDURES. VISUAL ANALYSIS REVEALED NO DAMAGE OR ANOMALIES ON THE DEVICE. THE DEVICE FEATURES WERE REVIEWED, AND NO ISSUES WERE OBSERVED DURING THE PRODUCT INVESTIGATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 31510067L NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. NO MALFUNCTION WAS OBSERVED DURING THE PRODUCT ANALYSIS. THE POTENTIAL CAUSE OF THE ADVERSE EVENT REMAINS UNKNOWN. IN ADDITION, NO DEVICE MALFUNCTION WAS REPORTED, THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT COULD NOT BE REPLICATED DURING THE ANALYSIS. THE INSTRUCTION FOR USE (IFU) STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED TO AVOID CARDIAC DAMAGE, PERFORATION, OR TAMPONADE. AS PART OF THE QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THIS PRODUCT COMPLAINT WILL BE ADDRESSED THROUGH THE QUALITY SYSTEM. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION CARDIAC ABLATION WITH A QDOT MICRO¿ CATHETER, AND THE PATIENT EXPERIENCED PERICARDIAL EFFUSION WITH PRESSURE TREATED WITH PERICARDIOCENTESIS. THE INFORMATION INDICATED THAT DURING THE CASE, A PERICARDIAL EFFUSION OCCURRED, AND A SPIKE IN FORCE WHILE THEY WERE ABLATING. THEY NOTICED THAT THE PATIENT¿S BLOOD PRESSURE HAD DROPPED, AND PERICARDIAL EFFUSION CONFIRMED ON ICE (INTRACARDIAC ECHOCARDIOGRAPHY). A PERICARDIOCENTESIS WAS PERFORMED ON THE PATIENT. THE PATIENT LAST KNOWN STATUS WAS RECOVERING IN THE (ICU) INTENSIVE CARE UNIT AND POTENTIALLY WILL BE RELEASED THE DAY OF OR THE NEXT. IT WAS LATER CONFIRMED THAT THE PATIENT DID NOT UNDERGO EXTENDED/PROLONGED HOSPITALIZATION. IT IS BELIEVED THE INJURY WAS CAUSED BY RESPIRATORY MOTION DURING ABLATION. A A QDOT CATHETER, A SOUNDSTAR CATHETER, NGEN GENERATOR, AND AN OCTARAY CATHETER WERE USED DURING THE PROCEDURE. THE QDOT CATHETER WAS AVAILABLE FOR RETURN. INFORMATION RECEIVED INDICATED THAT THE EVENT OCCURRED DURING THE CASE AFTER USE OF BWI PRODUCTS. THE PHYSICIANS OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS PROCEDURE RELATED. THE EVENT WAS TREATED WITH PERICARDIOCENTESIS, AND THE PATIENT FULLY RECOVERED (NO SIDE EFFECTS). NO EXTENDED HOSPITALIZATION NOTED. THE ACTIVATED CLOTTING TIME (ACT) WAS 350 SECONDS. NO CATHETER EXCHANGES NOTED, AND 2 TRANSEPTAL PUNCTURE SITES WERE PERFORMED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502563 QDOT MICRO¿ CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE BIOSENSE WEBSTER INC 31510067L 10846835017076

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Life Threatening| R CARTO 3 SYSTEM.| NGEN GENERATOR.