BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QDOT MICRO

    MDR report key: 22994108 · Received September 8, 2025

    Report

    Report Number
    2029046-2025-03044
    Event Type
    Injury
    Date Received
    September 8, 2025
    Date of Event
    August 12, 2025
    Report Date
    October 10, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAE
    UDI-DI
    10846835016758
    PMA / PMN Number
    P210027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. INVESTIGATION IS IN PROGRESS, ONCE COMPLETED A SUPPLEMENTAL WILL BE SUBMITTED. 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

    THE INVESTIGATION WAS COMPLETED ON (B)(6) 2025. AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 31608207L AND NO NON-CONFORMANCES RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. IF THE PRODUCT IS RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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

    DURING AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A QDOT MICRO CATHETER, THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT WAS TREATED WITH DRAINAGE. IN ADDITION, THE VIZIGO SHEATH HAD AIR LEAKAGE DRAWN FROM THE SIDE PORT. DURING THE LEFT PULMONARY VEIN (LPV) ISOLATION, THE POSITION OF THE HEART CHANGED SIGNIFICANTLY. THE SOUND STAR ECO CATHETER REVEALED THE PERICARDIAL EFFUSION. THE PHYSICIAN COMMENTED THAT WHEN THE ABLATION WAS CONDUCTED ON THE ANTERIOR WALL OF THE LEFT SUPERIOR PULMONARY VEIN (LSPV) NEAR THE ROOF, THE PATIENT, WHO HAD BEEN APNEIC UNTIL THEN, SUDDENLY TOOK A DEEP BREATH, CAUSING THE CONTACT FORCE TO RAPIDLY INCREASE (MAXIMUM LESS THAN 40G). ABLATION WAS PERFORMED ONLY IN THE LPV BEFORE THE TAMPONADE WAS CONFIRMED. THE PHYSICIAN CONSIDERED THAT THIS ABLATION MIGHT HAVE BEEN THE CAUSE. AFTER THE CARDIAC TAMPONADE WAS CONFIRMED, THE PROCEDURE WAS TERMINATED. THE TREATMENT WAS PROVIDED BY CONFIRMING THE PERICARDIAL EFFUSION WITH INTRACARDIAC ECHOCARDIOGRAPHY (ICE), AND THEN THE PATIENT WAS RETURNED TO THE PATIENT¿S ROOM. ATRIAL SEPTAL PUNCTURE WAS PERFORMED WITH THE RF NEEDLE. NO STEAM POP WAS CONFIRMED. THE QDOT MICRO CATHETER WAS USED AT 50W AND 90W WITH THE PRESCRIBED FLOW RATE FOR EACH POWER SETTING. WHEN THE PROCEDURE WAS TERMINATED, THE PHYSICIAN POINTED OUT THAT AIR WAS DRAWN FROM THE VIZIGO SHEATH. THE HEMOSTATIC VALVE WAS NOT DISLODGED. ADDITIONAL INFORMATION WAS RECEIVED ON 15-AUG-2025. DRAINAGE WAS PERFORMED BY CHECKING THE PERICARDIAL EFFUSION WITH INTRACARDIAC ECHOCARDIOGRAPHY (ICE). AFTER CONFIRMING THE REDUCTION OF THE PERICARDIAL EFFUSION, THE PATIENT RETURNED TO THE PATIENT¿S ROOM. IMMEDIATELY AFTER THE PERICARDIAL EFFUSION WAS CONFIRMED, DRAINAGE WAS PERFORMED. NEXT DAY, THE PHYSICIAN CONFIRMED THAT THERE WERE NO PROBLEMS WITH THE PATIENT¿S PROGRESS. PHYSICIAN ASSESSMENT OF THE HEALTH PROBLEM WAS NON-SERIOUS (MODERATE/MINOR). NO EXTENDED HOSPITALIZATION. CONTACT FORCE MONITORING METHODS WERE DASHBOARD, VECTOR, AND VISITAG. COLORING SETTING FOR VISITAG WAS TAG INDEX. THE PHYSICIAN CONSIDERED THAT THE EVENT MIGHT HAVE BEEN CAUSED BY THE PATIENT¿S SUDDEN CHANGE IN RESPIRATION. NO ABNORMALITIES OBSERVED PRIOR TO USE OF THE PRODUCT, BUT THERE WERE ABNORMALITIES OBSERVED DURING USE OF THE PRODUCT. ADDITIONAL INFORMATION WAS RECEIVED ON 17-AUG-2025. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS THE PATIENT¿S CONDITION. THE PHYSICIAN COMMENTED THAT DURING ABLATION NEAR THE ANTERIOR WALL ROOF OF THE LSPV, THE PATIENT, WHO HAD BEEN APNEIC UNTIL THEN, SUDDENLY TOOK A DEEP BREATH, AND THE CF SHARPLY INCREASED (MAX: UNDER 40 G), SUGGESTING THAT ABLATION AT THAT TIME MIGHT HAVE BEEN THE CAUSE. THE OUTCOME OF THE ADVERSE EVENT WAS IMPROVED. RF NEEDLE WAS USED FOR TRANSSEPTAL PUNCTURE. PRIOR TO NOTING THE PERICARDIAL EFFUSION, ABLATION WAS PERFORMED. THE PATIENT DID NOT REQUIRE CARDIAC SURGERY. THE EVENT OCCURRED MAYBE DURING THE ABLATION PHASE. THE VIZIGO SHEATH HAD AIR LEAKAGE. THE HEMOSTASIS VALVE (GASKET) DID NOT DISLODGE INSIDE THE HUB. NO AIR ENTERED THE PATIENT¿S BODY. NO BLOOD RETURN WAS OBSERVED. THE SHEATH WAS BEING USED ON THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 03-SEP-2025. THE AIR LEAKAGE WAS DRAWN FROM THE SIDE PORT. THE AIR DRAWN FROM THE VIZIGO SHEATH (AIR LEAKAGE DRAWN FROM THE SIDE PORT) WAS ASSESSED AS A MDR REPORTABLE MALFUNCTION UNDER THE VIZIGO SHEATH (2029046-2025-03042). THE FORCE ISSUE 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 ADVERSE EVENT WAS ASSESSED AS MDR REPORTABLE UNDER THE QDOT MICRO CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1915479 QDOT MICRO CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE BIOSENSE WEBSTER INC 31608207L 10846835016758

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Life Threatening| R 8.5F SHEATH, VIZ SMCURVE,SHORT| OCTA,LNG,48P,3-3-3-3-3,D-CURVE| RF NEEDLE| SOUNDSTAR ECO SMS 8F CATHETER| UNK_CARTO 3| UNK_NGEN PUMP| UNK_NGEN RF GENERATOR