BEUDAMED
    FDA Adverse Event Death Summary report: N

    QDOT MICRO

    MDR report key: 23705360 · Received December 3, 2025

    Report

    Report Number
    2029046-2025-03988
    Event Type
    Death
    Date Received
    December 3, 2025
    Date of Event
    November 3, 2025
    Report Date
    January 29, 2026
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAD
    PMA / PMN Number
    P210027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. HOWEVER, IF THE PRODUCT OR PRODUCT ID NUMBERS ARE RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. 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

    ADDITIONAL INFORMATION WAS RECEIVED ON 29-JAN-2026. THE DATE OF DEATH WAS (B)(6) 2025. THE PHYSICIAN¿S OPINION REGARDING THE CAUSE OF DEATH WAS THAT THE PATIENT SHOWED SIGNS OF PERICARDIAL EFFUSION A FEW HOURS AFTER THE PROCEDURE. EMERGENCY MEASURES INCLUDING REANIMATION WERE TAKEN, BUT MAY HAVE COME TOO LATE, SO PATIENT DIED OF THE AFTEREFFECTS, MOST LIKELY TO HYPOXIC BRAIN DAMAGE. THEREFORE, UPDATED THE "B2. DATE OF DEATH" FIELD AND "H6. HEALTH EFFECT - CLINICAL CODE" FIELD. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    IN THE 3500A FOLLOW-UP #1 UNDER "H11. ADDITIONAL MANUFACTURER NARRATIVE" REPORTED, "ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION OF THE PATIENT¿S DATE OF DEATH. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. THEREFORE, WITH THE INFORMATION AVAILABLE, ADDED THE ESTIMATED DATE OF DEATH AS ON (B)(6) 2025 (DATE OF ADDITIONAL INFORMATION PROVIDING THAT THE OUTCOME OF THE ADVERSE EVENT WAS DEATH)." HOWEVER, SINCE NO DATE OF DEATH WAS PROVIDED, CORRECTED THE "B2. DATE OF DEATH" FIELD BY REMOVING THE ESTIMATED DATE OF DEATH. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 08-DEC-2025. THE ADVERSE EVENT WAS DISCOVERED POST USE/FEW HOURS OF BIOSENSE WEBSTER PRODUCTS/PROCEDURE. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS UNKNOWN; DELAYED PERICARDIAL EFFUSION WITH TAMPONADE. THE INTERVENTION PROVIDED WAS REANIMATION, PERICARDIOCENTESIS, AND SURGERY. THE OUTCOME OF THE ADVERSE EVENT WAS DEATH (HYPOXIC BRAIN DAMAGE, WITHDRAWAL OF ICU THERAPY). THE PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE THE PATIENT WAS STABLE AND UNOBTRUSIVE DIRECTLY AFTER THE PROCEDURE AND WENT TO ICU FOR FURTHER SURVEILLANCE. LATER THAT AFTERNOON, THE PATIENT¿S CONDITION SUDDENLY WORSENED. THE PROCEDURAL ACT DURING PROCEDURE WAS BETWEEN 300 AND 400 SECONDS. THE SHEATH AND THE CATHETERS WERE EXCHANGED ONE FOR SHEATH AFTER TRANSSEPTAL PUNCTURE (TSP WAS PERFORMED WITH ABBOTT SL1, THEN SWITCHED TO VIZIGO), AND CATHETERS 2 TIMES. ONE TRANSSEPTAL PUNCTURE SITE WAS PERFORMED DURING THE PROCEDURE. THE ABLATIONS WERE DELIVERED IN QMODE AND QMODE+ ABLATIONS. THE ISSUE OF ¿BLACK-AND-WHITE NOISE IMAGE¿ REFERS TO THE "CATHETER VIEW" TOOLBAR IN THE CARTO SYSTEM AND APPEARED OCCASIONALLY. THE TEMPERATURE MEASUREMENT OF THE QDOT WAS WORKING AS INTENDED AND DISPLAYED BOTH IN THE CARTO GRAPHS VIEWER AND THE NGEN MONITORS. THE TEMPERATURE MEASUREMENT SHOWED NO NOTICEABLE LARGE OR LOW VALUES. THE ISSUE COULD LATER BE FIXED BY EXCHANGING THE QDOT DONGLE. NGEN GENERATOR AND PUMP WERE USED FOR THE PROCEDURE, AND NO SERVICE NEEDED. THEREFORE, UPDATED THE FOLLOWING FIELDS: -D10. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES SECTION - B2. IS DEATH IS CHECKED - B2. IS HOSPITALIZATION INITIAL/PROLONGED IS CHECKED - H1. TYPE OF REPORTABLE EVENT PROCESSED AS DEATH -H6. MEDICAL DEVICE PROBLEM CODE REMOVED PATIENT DEVICE INTERACTION PROBLEM (A01) AND ADDED ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR USE PROBLEM (A24) -H6. HEALTH EFFECT - IMPACT CODE ADDED HOSPITALIZATION OR PROLONGED HOSPITALIZATION (F08) AND DEATH (F02). ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION OF THE PATIENT¿S DATE OF DEATH. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. THEREFORE, WITH THE INFORMATION AVAILABLE, ADDED THE ESTIMATED DATE OF DEATH AS (B)(6) 2025 (DATE OF ADDITIONAL INFORMATION PROVIDING THAT THE OUTCOME OF THE ADVERSE EVENT WAS DEATH). 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 ATYPICAL FLUTTER PROCEDURE WITH A QDOT MICRO CATHETER AND AFTER THE PROCEDURE, THE PATIENT EXPERIENCED REANIMATION AND PERICARDIAL EFFUSION TREATED WITH PERICARDIAL PUNCTURE. ADDITIONALLY, BLEEDING FROM THE STOMACH WHICH REQUIRED SURGERY. WHILE PERFORMING THE PROCEDURE YESTERDAY AFTERNOON, THE PROCEDURE WENT VERY WELL, WITHOUT ANY PROBLEMS DURING ACCESS OR MAPPING PHASE. THE PHYSICIAN DIAGNOSED AN ATYPICAL FLUTTER, RUNNING OVER THE ATRIAL ROOF AND WANTED TO ABLATE OVER THE POSTERIOR ROOF TO END THE TACHYCARDIA. UPON CONNECTION OF THE QDOT MICRO CATHETER, WE NOTICED THAT THE CATHETER VIEW BULLSEYE SHOWED NO TEMPERATURE MEASUREMENT, BUT ONLY BLACK AND WHITE NOISE IMAGE. THE TEMPERATURE MEASUREMENT IN THE GRAPH VIEWER AND IN THE NGEN, MONITOR WAS WORKING NORMALLY AND SHOWED RELIABLE VALUES. THEREFORE, THE PHYSICIAN DID NOT WISH TO REPLACE CATHETER OR CABLE AND CONTINUED WITH THE ABLATION. TACHYCARDIA WAS TERMINATED IMMEDIATELY AFTER ABLATING THE POSTERIOR WALL AND PARTS OF THE POSTERIOR PULMONARY VEINS, AND THE PROCEDURE WAS FINISHED WITHOUT ANY IMMEDIATE ISSUES. ECHO WAS PERFORMED TO CHECK PERICARDIUM, WITHOUT ANY VISIBLE DAMAGE. HOWEVER, TODAY, THE PHYSICIAN INDICATED THAT THE PATIENT HAD TO BE REANIMATED LATER ON BECAUSE OF PERICARDIAL EFFUSION. THE PHYSICIAN DID NOT KNOW WHERE OR WHEN IN THE PROCEDURE THE EFFUSION OCCURRED, EVERYTHING WAS NORMAL DURING THE PROCEDURE. THE PATIENT RECEIVED EMERGENCY TREATMENT YESTERDAY IN THE EVENING INCLUDING PERICARDIAL PUNCTURE AND COULD BE STABILIZED AGAIN. HOWEVER, THE PATIENT IS GOING TO THE OP TO GET SURGERY, BECAUSE OF BLEEDING FROM THE STOMACH, LIKELY DUE TO EMERGENCY PUNCTURE YESTERDAY. THE PATIENT REQUIRED REVISION SURGERY ON (B)(6) 2025. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION OF THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2787285 QDOT MICRO CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| R| H| D 6FR CS, F,10 POLE,12 PIN, AUTOID.| 8.5F SHEATH WITH CURVE VIZ SMC.| ABBOTT SL1 SHEATH.| NGEN PUMP, EU CONFIGURATION.| NGEN RF GENERATOR.| OCTA, LNG,48P,3-3-3-3-3, D-CURVE.| UNK CABLE.| UNK NGEN.| UNK_CARTO 3.