BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QDOT-MICRO, BI-DIRECTIONAL, D-F CURVE, C3, SPLIT HANDLE

    MDR report key: 13584312 · Received February 23, 2022

    Report

    Report Number
    2029046-2022-00363
    Event Type
    Injury
    Date Received
    February 23, 2022
    Date of Event
    January 27, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    UDI-DI
    10846835016758
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE INVESTIGATION DETAILS: THE DEVICE HAS BEEN REPORTED AS DISCARDED, THEREFORE NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. A MANUFACTURING RECORD EVALUATION (MRE) CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. NOTE: THE ¿SUSPECTED MEDICAL DEVICE¿ REPORTED IN THIS REPORT IS NOT MARKETED IN USA OR APPROVED BY THE FDA. HOWEVER, IT IS BEING REPORTED AS BIOSENSE WEBSTER CONSIDERS THIS AS A SIMILAR DEVICE TO (B)(6) SF BI-DIRECTIONAL NAVIGATION CATHETER APPROVED UNDER (B)(4). IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).

    Additional Manufacturer Narrative · 0

    DEVICE INVESTIGATION DETAILS: THE DEVICE HAS BEEN REPORTED AS DISCARDED, THEREFORE NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. A MANUFACTURING RECORD EVALUATION (MRE) CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. NOTE: THE ¿SUSPECTED MEDICAL DEVICE¿ REPORTED IN SECTION D OF THIS REPORT IS NOT MARKETED IN USA OR APPROVED BY THE FDA. HOWEVER, IT IS BEING REPORTED AS BIOSENSE WEBSTER CONSIDERS THIS AS A SIMILAR DEVICE TO THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER APPROVED UNDER P030031/S078. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A (B)(6) MALE ((B)(6)) UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A (B)(6), BI-DIRECTIONAL, D-F CURVE, C3, SPLIT HANDLE AND THE PATIENT SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS.CARDIAC TAMPONADE WAS DISCOVERED POST ABLATION. PERICARDIUM DRAINAGE WAS PERFORMED AND 800ML OF LIQUID WERE EVACUATED. THERE IS NO FURTHER INFORMATION ABOUT THE HOSPITALIZATION OR PATIENT STATUS.ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION/ADDITIONAL INFORMATION FOR THIS EVENT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A (B)(6) MALE (184CM, (B)(6)) UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A QDOT-MICRO, BI-DIRECTIONAL, D-F CURVE, C3, SPLIT HANDLE AND THE PATIENT SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. CARDIAC TAMPONADE WAS DISCOVERED POST ABLATION. PERICARDIUM DRAINAGE WAS PERFORMED AND 800ML OF LIQUID WERE EVACUATED. THERE IS NO FURTHER INFORMATION ABOUT THE HOSPITALIZATION OR PATIENT STATUS. ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION/ADDITIONAL INFORMATION FOR THIS EVENT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1147352 QDOT-MICRO, BI-DIRECTIONAL, D-F CURVE, C3, SPLIT HANDLE SIMILAR DEVICE D134801, PMA # P030031/S078 DRF BIOSENSE WEBSTER INC 10846835016758

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Life Threatening| R