BEUDAMED
    FDA Adverse Event Death Summary report: N

    QDOT MICRO

    MDR report key: 19182778 · Received April 25, 2024

    Report

    Report Number
    2029046-2024-01365
    Event Type
    Death
    Date Received
    April 25, 2024
    Date of Event
    March 28, 2024
    Report Date
    April 25, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAE
    UDI-DI
    10846835017045
    PMA / PMN Number
    P210027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE IT WAS UNKNOWN EXACTLY WHICH DATE THE PATIENT PASSED; HOWEVER, IT WAS REPORTED THAT HE PASSED OVER THE WEEKEND, PROCESSED THE FIELD B2. DATE OF DEATH AS (B)(6) 2024. THE DEVICE HAS BEEN REPORTED AS DISCARDED, THEREFORE NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD EVALUATION (MRE) CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. 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 ABLATION WITH A QDOT MICRO CATHETER AND THE PATIENT DIED. REAL AF STUDY. IT WAS REPORTED THAT THE PATIENT PASSED AWAY OVER THE WEEKEND. THEY HAD ISSUES ISOLATING THE RIGHT PULMONARY VEINS. THEY MAPPED AND REMAPPED FOR BREAK THROUGH MULTIPLE TIMES WITH THE OCTARAY, WOULD FIND MULTIPLE BREAK THROUGHS AND WOULD BURN THEM BUT COULD NOT GET THE RIGHT VEINS TO ISOLATE. IT WAS NOTED THAT THEY HAD SOME ISSUES WITH THE LEFT VEINS BUT NOT AS SIGNIFICANTLY AS THEY DID ON THE RIGHTS. AFTER SO MUCH BURNING ON THE RIGHTS THEY FINALLY GAVE UP AS IT WAS BELIEVED THEY COULD NOT KEEP BURNING WITHOUT CAUSING HARM TO THIS PATIENT SO THEY DECIDED TO LEAVE THEM CONNECTED. THEY CHECKED FOR EFFUSION USING THE INTRACARDIAC ECHOCARDIOGRAPHY (ICE) CATHETER AT THE END AND THERE WAS A TRACE EFFUSION. THE PHYSICIAN DECIDED NOT TO TAP THE PATIENT AND JUST TO KEEP AN EYE ON THEM. IT WAS REPORTED, "I GUESS THEY RAPIDLY DECLINED AND PASSED OVER THE WEEKEND.¿ THE PHYSICIAN THINKS IT MIGHT HAVE BEEN A PULMONARY EMBOLISM BUT WAS UNSURE. THE EFFUSION WAS VERY MODERATE, MILD, THEY LEFT THE ROOM AND IT WAS PRETTY QUICK. ADDITIONAL INFORMATION WAS RECEIVED. TRANSSEPTAL PUNCTURE WAS PERFORMED. ABLATION WAS PERFORMED PRIOR TO NOTING THE PERICARDIAL EFFUSION. NO EVIDENCE OF STEAM POP. NO ERROR MESSAGES OBSERVED ON BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE. PHYSICIAN'S OPINION ON THE CAUSE OF DEATH IS POSSIBLE "PE" BUT UNSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1614663 QDOT MICRO CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE BIOSENSE WEBSTER INC 10846835017045

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death CARTO 3 SYSTEM PIU| DECANAV CATHETER| NGEN SYSTEM| OCTARAY CATHETER| SOUNDSTAR CATHETER| UNK PUMP