BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LASSOSTAR, 10P, DIA 15MM LOOP SIZE

    MDR report key: 16936827 · Received May 16, 2023

    Report

    Report Number
    2029046-2023-01033
    Event Type
    Malfunction
    Date Received
    May 16, 2023
    Date of Event
    January 1, 2022
    Report Date
    May 15, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    PMA / PMN Number
    K193632
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    B3. DATE OF EVENT: THE EVENT DATE IS UNKNOWN. AS A RESULT, THE 1ST DAY OF THE YEAR HAS BEEN ENTERED AS THE EVENT DATE. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE ON 27-MAR-2023. THE DEVICE EVALUATION WAS COMPLETED ON 18-APR-2023. THE LASSOSTAR CATHETER PRODUCT WAS RETURNED TO BIOSENSE WEBSTER INC. (BWI) FOR EVALUATION. BWI CONDUCTED A VISUAL INSPECTION TEST OF THE RETURNED DEVICE. THE DEVICE WAS VISUALLY INSPECTED AND WAS FOUND THE SHAFT BENT AND BROKEN AT THE MIDDLE SECTION WITH ELECTRICAL WIRES EXPOSED. THE ROOT CAUSE OF THE CONDITION OBSERVED COULD BE RELATED TO THE HANDLING OF THE DEVICE; HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 30684371L NUMBER, AND NO INTERNAL ACTION WAS FOUND DURING THE REVIEW. THE ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED. IT SHOULD BE NOTED THAT PRODUCT FAILURE IS MULTIFACTORIAL. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING RECOMMENDATIONS: IF A LASSOSTAR¿ CATHETER IS USED WITH THE HELIOSTAR¿ CATHETER, DO NOT EXTEND THE HELIOSTAR¿ CATHETER BEYOND THE SHEATH TIP UNTIL THE LASSOSTAR¿ CATHETER HAS BEEN FULLY ADVANCED OUT OF THE GUIDEWIRE LUMEN. AS PART OF BIOSENSE WEBSTER'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THIS PRODUCT ISSUE WILL BE ADDRESSED THROUGH BWI'S QUALITY SYSTEM. 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 A PULMONARY VEIN ISOLATION (PVI) CARDIAC ABLATION PROCEDURE WITH A LASSOSTAR, 10P, DIA 15MM LOOP SIZE AND THE BIOSENSE WEBSTER INC, (BWI) PRODUCT ANALYSIS LAB OBSERVED THE SHAFT BENT AND BROKEN AT THE MIDDLE SECTION WITH ELECTRICAL WIRES EXPOSED. INITIALLY, IT WAS REPORTED THAT THE LASSOSTAR LOOKED DAMAGED WHEN PULLING IT OUT OF THE BALLOON CATHETER DURING BALLOON CHANGE. ANOTHER LASSOSTAR WAS USED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. THE SHAFT BENT WAS ASSESSED AS NOT MDR REPORTABLE. THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, IS REMOTE. THIS EVENT IS BEING REPORTED BECAUSE THE BIOSENSE WEBSTER INC, (BWI) PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND FOUND ON 18-APR-2023 THAT THE SHAFT WAS BENT AND BROKEN AT THE MIDDLE SECTION WITH ELECTRICAL WIRES EXPOSED THIS FINDING WAS ASSESSED AS MDR REPORTABLE. THE AWARENESS DATE FOR THIS REPORTABLE LAB FINDING IS 18-APR-2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474717 LASSOSTAR, 10P, DIA 15MM LOOP SIZE LASSOSTAR¿ CIRCULAR MAPPING CATHETER DRF BIOSENSE WEBSTER INC 30684371L

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown