BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QDOT-MICRO, UNI-DIRECTIONAL, F CURVE, C3, SPLIT HANDLE

    MDR report key: 17789493 · Received September 21, 2023

    Report

    Report Number
    2029046-2023-02140
    Event Type
    Malfunction
    Date Received
    September 21, 2023
    Date of Event
    July 6, 2023
    Report Date
    September 21, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAE
    UDI-DI
    10846835017076
    PMA / PMN Number
    P210027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE ON 01-AUG-2023. THE DEVICE EVALUATION WAS COMPLETED ON 30-AUG-2023. THE QDOT MICRO DEVICE WAS RETURNED TO BIOSENSE WEBSTER (BWI) FOR EVALUATION. A VISUAL INSPECTION OF THE RETURNED DEVICE WAS PERFORMED FOLLOWING BWI PROCEDURES. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED A HOLE AND REDDISH MATERIAL IN THE PEBAX. THE ROOT CAUSE OF THE DAMAGE ON PEBAX CANNOT BE RELATED TO THE MANUFACTURING PROCESS SINCE THERE IS EVIDENCE THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATIONS AND PROCEDURES. IT COULD BE RELATED TO THE HANDLING OF THE DEVICE DURING THE PROCEDURE; HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 31061633L NUMBER, AND NO INTERNAL ACTION WAS FOUND DURING THE REVIEW. THE ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED. IT SHOULD BE NOTED THAT PRODUCT FAILURE IS MULTIFACTORIAL. AS PART OF BIOSENSE WEBSTER'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THIS PRODUCT ISSUE WILL BE ADDRESSED THROUGH BWI'S QUALITY SYSTEM. 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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION AFIB - PAROXYSMAL PROCEDURE WITH QDOT-MICRO, UNI-DIRECTIONAL, F CURVE, C3, SPLIT HANDLE FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A HOLE IN THE PEBAX. INITIALLY IT WAS REPORTED THAT DURING ABLATION, IT WAS NOTICED THAT THE FORCE WOULD IMMEDIATELY SURGE SO THE ABLATION WAS STOPPED. AFTER REPLACING THE CABLE, THE ERROR PERSISTED. ABLATION WAS THEN ATTEMPTED AFTER MAKING SURE THAT THERE WAS NO CONTACT TO THE TISSUE AT ALL (NO SIGNAL, FORCE AT 0, NO CONTACT IN 3DMAP, NO CONTACT IN FLUORO) WHICH RESULTED IN THE SAME. FORCE WOULD IMMEDIATELY SURGE FROM 0 TO 30/40/50+ WITHIN SECONDS. THE CATHETER WAS THEN REMOVED, AND IT WAS NOTICED THAT WHAT APPEARED TO BE BLOOD HAS AMASSED IN THE CATHETER TIP (AROUND THE FORCE VECTOR). THE REASON FOR THIS IS UNKNOWN SINCE ALL PREPARATIONS INCLUDING FLUSHING OF THE CATHETER WERE DONE WITHOUT ANY ISSUES. THE CATHETER WAS THEN REPLACED, AND THE PROCEDURE WAS FINISHED WITHOUT ANY MORE ISSUES. THERE WAS A DELAY OF TEN MINUTES. THERE WAS NO PHYSICAL DAMAGE NOTICED ON THE CATHETER BEFORE THE PROCEDURE. AFTER THE PROCEDURE, PHYSICAL DAMAGE WAS DIFFICULT TO EXAMINE DUE TO THE BLOOD IN THE TIP. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED. THE NGEN GENERATOR CONSOLE SOFTWARE VER. 2.0.27.273114 WAS USED (NGEN MONITOR¿S SOFTWARE VERSION: 2.0.27.61). NO OTHER GENERATOR WAS USED. THE FOREIGN MATERIAL WHICH APPEARED TO BE BLOOD WAS ASSESSED AS NON MDR REPORTABLE. THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH TO THE OPERATOR OR PATIENT WAS REMOTE. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND PER THE EVALUATION COMPLETION ON 30-AUG-2023, THERE WAS A HOLE AND REDDISH MATERIAL IN THE PEBAX. THE HOLE IN THE PEBAX WAS ASSESSED AS MDR REPORTABLE. THE AWARENESS DATE FOR THIS REPORTABLE LAB FINDING WAS 30-AUG-2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1586044 QDOT-MICRO, UNI-DIRECTIONAL, F CURVE, C3, SPLIT HANDLE CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE BIOSENSE WEBSTER INC 31061633L 10846835017076

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown 8.5F SHEATH WITH CURVE VIZ SMC| NGEN RF GENERATOR| UNK BRAND CABLE