BEUDAMED
    FDA Adverse Event Death Summary report: N

    QDOT MICRO¿ CATHETER

    MDR report key: 19061056 · Received April 8, 2024

    Report

    Report Number
    2029046-2024-01151
    Event Type
    Death
    Date Received
    April 8, 2024
    Date of Event
    March 12, 2024
    Report Date
    October 9, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAE
    UDI-DI
    10846835017076
    PMA / PMN Number
    P210027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON 6-MAY-2024, THE PRODUCT INVESTIGATION WAS COMPLETED AS THE COMPLAINT DEVICE WAS NOT RETURNED. SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 31252031L AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. 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

    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). BIOSENSE WEBSTER MANUFACTURER'S REFERENCE NUMBER (B)(4) HAS 2 REPORTS. MANUFACTURER REPORT NUMBER 2029046-2024-01150 FOR THE FIRST QDOT MICRO¿ CATHETER. MANUFACTURER REPORT NUMBER 2029046-2024-01151 FOR THE REPLACEMENT QDOT MICRO¿ CATHETER (THIS CURRENT REPORT).

    Additional Manufacturer Narrative · 0

    D4 PRIMARY UDI NUMBER HAS BEEN UPDATED TO (B)(4). ON 2-SEP-2024, THE BWI PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. IT WAS REPORTED THAT A PATIENT UNDERWENT AN ISCHEMIC VENTRICULAR TACHYCARDIA (ISVT) ABLATION PROCEDURE THAT INCLUDED THE USAGE OF TWO DIFFERENT QDOT MICRO¿ CATHETERS AND THE PATIENT EXPERIENCED CARDIAC PERFORATION THAT REQUIRED MEDICATION AND BLOOD TRANSFUSION. THIS OCCURRED ON (B)(6) 2024. POST-PROCEDURE, THE PATIENT ULTIMATELY DIED. FIRST, IT WAS REPORTED THAT THE QDOT CATHETER RECEIVED A FORCE SENSOR ERROR AND A FORCE DATA STREAMING ERROR 279. THE MEDICAL TEAM COULD NOT ZERO THE QDOT CATHETER IN QUESTION. THE ABLATION CABLE WAS REPLACED WITHOUT RESOLUTION. THE CATHETER WAS REPLACED WITH A SECOND QDOT AND THE ISSUE RESOLVED. THE CASE CONTINUED AND WAS COMPLETED. DEVICE EVALUATION DETAILS: THE PRODUCT WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J) FOR EVALUATION. A VISUAL INSPECTION AND REVISION OF ALL FEATURES WERE PERFORMED FOLLOWING J&J PROCEDURES. VISUAL ANALYSIS REVEALED NO DAMAGE OR ANOMALIES ON THE DEVICE. THE DEVICE FEATURES WERE REVIEWED BY CONNECTING THE DEVICE TO THE CARTO 3 SYSTEM, AND NO ISSUES OR ERRORS WERE OBSERVED DURING THE PRODUCT INVESTIGATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 31252031L AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. NO MALFUNCTION WAS OBSERVED DURING THE PRODUCT ANALYSIS. THE ROOT CAUSE OF THE ADVERSE EVENT REMAINS UNKNOWN. IN ADDITION, NO DEVICE MALFUNCTION WAS REPORTED, THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT COULD NOT BE REPLICATED DURING THE ANALYSIS. THE INSTRUCTION FOR USE (IFU) STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED TO AVOID CARDIAC DAMAGE, PERFORATION, OR TAMPONADE. AS PART OF THE JOHNSON & JOHNSON MEDTECH QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. 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

    PER INTERNAL REVIEW ON 9-OCT-2024, IT WAS DISCOVERED THAT BWI HAD RECEIVED ADDITIONAL EVENT INFORMATION THAT WAS MISTAKENLY OMITTED FROM THE PREVIOUSLY SUBMITTED SUPPLEMENTAL REPORT. THE OMITTED INFORMATION GOES AS FOLLOWS: ON 19-SEP-2024, BWI RECEIVED ADDITIONAL INFORMATION REGARDING THE EVENT. THE QDOT CATHETER THAT HAD THE ERRORS WAS USED IN THE PATIENT. NO FURTHER EXPLANATION OF THE PERFORATION WAS PROVIDED, ONLY THAT IT WAS SUSPECTED AS THE CAUSE OF THE COMPLICATION. SHEATH USED WAS AN AGILIS SHEATH. THE PHYSICIAN DID NOT MENTION MUCH ABOUT THE DEATH, BESIDES THE THOUGHT THAT THERE MUST HAVE BEEN A PERFORATION AT SOME POINT DUE TO THE AMOUNT OF BLOOD THAT WAS SEEN. 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 ISCHEMIC VENTRICULAR TACHYCARDIA (ISVT) ABLATION PROCEDURE THAT INCLUDED THE USAGE OF TWO DIFFERENT QDOT MICRO¿ CATHETERS AND THE PATIENT EXPERIENCED CARDIAC PERFORATION THAT REQUIRED MEDICATION AND BLOOD TRANSFUSION. THIS OCCURRED ON (B)(6) 2024. POST-PROCEDURE, THE PATIENT ULTIMATELY DIED. FIRST, IT WAS REPORTED THAT THE QDOT CATHETER RECEIVED A FORCE SENSOR ERROR AND A FORCE DATA STREAMING ERROR 279. THE MEDICAL TEAM COULD NOT ZERO THE QDOT CATHETER IN QUESTION. THE ABLATION CABLE WAS REPLACED WITHOUT RESOLUTION. THE CATHETER WAS REPLACED WITH A SECOND QDOT AND THE ISSUE RESOLVED. THE CASE CONTINUED AND WAS COMPLETED. AFTER THE CASE, THE COMPLICATIONS THAT POSSIBLY CONTRIBUTED TO THE PATIENT'S DEATH WERE DISCOVERED. THE SURGEON STATED THAT THEY BELIEVED A CARDIAC PERFORATION OCCURRED. THE SURGEON BELIEVED THIS DUE TO THE AMOUNT OF BLEEDING THEY IDENTIFIED. THE INJURY WAS NOTICED AFTER THE CATHETERS WERE PULLED OUT OF THE PATIENT, BUT THE MEDICAL TEAM WAS UNSURE WHEN THE INJURY OCCURRED OR ITS EXACT LOCATION. THERE WAS ALSO EXCESSIVE BLEEDING FROM THE PATIENT'S GROIN. THE PATIENT HAD BEEN GIVEN BLOOD AND MEDICATIONS--BICARBONATE AND EPINEPHRINE. THE PATIENT PASSED AWAY ON THE NIGHT OF (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104660 QDOT MICRO¿ CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE BIOSENSE WEBSTER INC 31252031L 10846835017076

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death| R| L AGILIS SHEATH| CARTO 3 SYSTEM| DECANAV CATHETER| NGEN GENERATOR| NGEN PUMP| OCTARAY CATHETER