BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QDOT MICRO¿ CATHETER

    MDR report key: 20765347 · Received November 22, 2024

    Report

    Report Number
    2029046-2024-03770
    Event Type
    Malfunction
    Date Received
    November 22, 2024
    Date of Event
    January 1, 2024
    Report Date
    February 25, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAE
    UDI-DI
    10846835016758
    PMA / PMN Number
    P210027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    D4: UDI: THE EXPIRATION DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE. 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 28-JAN-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 ABLATION PROCEDURE WITH A QDOT MICRO¿ CATHETER AND THERE WAS CHARRING ON THE CATHETER TIP. THE MEDICAL TEAM BELIEVED THAT THE CHAR MUST HAVE HAPPENED DURING THE PULMONARY VEIN ISOLATION (PVI). AFTER AN ABLATION WITH A QDOT MICRO, THE CATHETER WAS REMOVED FROM THE PATIENT AND CHARRING WAS OBSERVED ON THE CATHETER TIP. THE CATHETER WAS USED IN QMODE+ ONLY (90W). THE PATIENT DIDN´T EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING. THERE WERE NO POST PROCEDURE NEUROLOGICAL SYMPTOMS EITHER. HOWEVER, THE PHYSICIAN CONSIDERED THE AMOUNT OF CHAR TO BE EXCESSIVE. NO FURTHER DETAILS WERE PROVIDED REGARDING COMPLETION OF THE PROCEDURE. DEVICE EVALUATION DETAILS: THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J) FOR EVALUATION. VISUAL INSPECTION, MICROSCOPIC EXAMINATION, SCANNING ELECTRON MICROSCOPY (SEM), IRRIGATION, TEMPERATURE, AND IMPEDANCE TEST OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING J&J PROCEDURES. ACCORDING TO THE PICTURES PROVIDED BY THE DECONTAMINATION SITE, CHAR RESIDUES WERE OBSERVED LOCATED AT THE BOTTOM OF THE DOME IN THE TRANSITION BETWEEN THE DOME AND THE FIRST RING; HOWEVER, DURING THE VISUAL ANALYSIS IN THE LAB, NO CHAR RESIDUES WERE IDENTIFIED. AFTERWARDS, A MICROSCOPIC INSPECTION OF THE DOME WAS PERFORMED, AND SOME IRRIGATION HOLES WERE OBSERVED OCCLUDED WITH A DRY WHITISH MATERIAL. DUE TO THE OCCLUSION IN THE IRRIGATION HOLES, EXCESS HEAT COULD BE GENERATED AT THE DOME SURFACE, WHICH COULD CAUSE AN INCREASE IN THE TEMPERATURE AND THE PRESENCE OF CHAR RESIDUES IN THIS AREA. A SEM TEST WAS PERFORMED TO IDENTIFY THE FOREIGN MATERIAL INSIDE THE IRRIGATION HOLE. IT WAS IDENTIFIED THAT THE OCCLUSION IS COMPOSED OF AN INORGANIC MATERIAL. DUE TO THIS CONDITION, FURTHER INVESTIGATION WAS CONDUCTED WITH THE MANUFACTURING TEAM TO IMPLEMENT ACTION TO SOLVE THIS FAILURE MODE. THE INVESTIGATION CONCLUDED THAT THE PRESENCE OF THE INORGANIC MATERIAL INSIDE THE IRRIGATION HOLE IS CONFIRMED TO BE MANUFACTURING ATTRIBUTABLE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 31437500L AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. THE CHAR ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED. THE POTENTIAL CAUSE OF THE OCCLUSION IS TRACED TO THE MANUFACTURING PROCESS. THE INSTRUCTION FOR USE (IFU) CONTAINS THE FOLLOWING WARNINGS AND PRECAUTIONS: MONITOR THE CATHETER TIP TEMPERATURE RESPONSE THROUGHOUT THE PROCEDURE TO ENSURE ADEQUATE IRRIGATION. IF TEMPERATURE INCREASES VERY RAPIDLY DURING RF (RADIOFREQUENCY) APPLICATION, POWER DELIVERY SHOULD BE INTERRUPTED. THE IRRIGATION SYSTEM MUST BE RECHECKED PRIOR TO RESTARTING RF APPLICATION. NOTE: THE DISPLAYED TEMPERATURE REPRESENTS THE TEMPERATURE OF THE ELECTRODE ONLY, NOT THE TEMPERATURE OF THE TISSUE. WHEN RF ENERGY IS INTERRUPTED FOR EITHER A TEMPERATURE OR AN IMPEDANCE RISE (THE SET LIMIT IS EXCEEDED), THE CATHETER SHOULD BE REMOVED, AND THE TIP SHOULD BE INSPECTED FOR CHAR/COAGULUM THAT MAY BE PRESENT ON THE TIP. IF PRESENT, DO NOT CONTINUE THE PROCEDURE WITH THE SAME CATHETER AND REPLACE THE CATHETER. IF NO CHAR/COAGULUM IS PRESENT, FLUSH THE TIP TO ENSURE THE IRRIGATION HOLES ARE NOT PLUGGED PRIOR TO REINSERTION OF THE CATHETER INSIDE THE PATIENT BODY. AN ESCALATION INVESTIGATION WAS ADDRESSED TO INVESTIGATE THE EVENT REPORTED BY THE CUSTOMER. AN INTERNAL ACTION IS BEING FOLLOWED TO REDUCE THE OCCLUSION FAILURE MODES. THIS PRODUCT ISSUE WILL BE ADDRESSED THROUGH J&J'S 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 ABLATION PROCEDURE WITH A QDOT MICRO¿ CATHETER AND THERE WAS CHARRING ON THE CATHETER TIP. THE MEDICAL TEAM BELIEVED THAT THE CHAR MUST HAVE HAPPENED DURING THE PULMONARY VEIN ISOLATION (PVI). AFTER AN ABLATION WITH A QDOT MICRO, THE CATHETER WAS REMOVED FROM THE PATIENT AND CHARRING WAS OBSERVED ON THE CATHETER TIP. THE CATHETER WAS USED IN QMODE+ ONLY (90W). THE PATIENT DIDN´T EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING. THERE WERE NO POST PROCEDURE NEUROLOGICAL SYMPTOMS EITHER. HOWEVER, THE PHYSICIAN CONSIDERED THE AMOUNT OF CHAR TO BE EXCESSIVE. NO FURTHER DETAILS WERE PROVIDED REGARDING COMPLETION OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1852363 QDOT MICRO¿ CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE BIOSENSE WEBSTER INC 31437500L 10846835016758

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown