BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LASSOSTAR NAV CIRCULAR MAPPING CATHETER

    MDR report key: 17964804 · Received October 19, 2023

    Report

    Report Number
    2029046-2023-02376
    Event Type
    Malfunction
    Date Received
    October 19, 2023
    Date of Event
    July 24, 2023
    Report Date
    October 19, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    UDI-DI
    10846835020335
    PMA / PMN Number
    K211219
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    **UDI RELATED DATA QUALITY UPDATES ONLY** CORRECTION TO THE INITIAL MDR, INCOMPLETE UDI WAS PROVIDED. SECTION D4. PRIMARY UDI NUMBER HAS BEEN UPDATED WITH FULL UDI (01)10846835020335(11)221019(17)231018(10)30929201L. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. NO: (B)(4).

    Additional Manufacturer Narrative · 0

    THE BWI PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON 25-AUG-2023. THE DEVICE EVALUATION WAS COMPLETED ON 22-SEP-2023. THE PRODUCT WAS RETURNED TO BIOSENSE WEBSTER FOR EVALUATION. BWI CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT A BENT WAS OBSERVED ON THE SHAFT. ADDITIONALLY, SOME RINGS WERE OBSERVED TO BE DAMAGED (I.E. DENTED AND SHARP EDGES), THE TIP SECTION WAS OBSERVED TO BE DAMAGED, AND THE INTERNAL COMPONENTS WERE EXPOSED. THIS CONDITION COULD BE RELATED TO EXCESSIVE FORCE OR MANIPULATION; HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. NO OTHER DAMAGES OR ABNORMALITIES WERE FOUND, THE ORIGINAL PACKAGE WAS NOT RETURNED TO THE ANALYSIS LAB. THE BENT CONDITION NOTED ON THE DEVICE MAY HAVE BEEN RELATED TO THE CUSTOMER COMPLAINT AND MAY HAVE APPEARED TO HAVE BEEN CAUSED BY EXCESSIVE FORCE AND HANDLING APPLIED TO THE DEVICE; HOWEVER, NONE OF THOSE CAN BE CONCLUSIVELY DETERMINED. THE CUSTOMER COMPLAINT WAS CONFIRMED. ALL UNITS ARE INSPECTED PRIOR TO LEAVING THE FACILITY AS THERE ARE FUNCTIONAL TESTS AND INSPECTIONS AT CONTROL POINTS BASED ON THE PROCESS FLOW DIAGRAM (PFD) PER ITS PART NUMBER TO AVOID THIS TYPE OF DAMAGE FROM LEAVING THE FACILITY. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO INTERNAL ACTIONS WERE IDENTIFIED. 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. EXPLANATION OF CODES: INVESTIGATION FINDINGS: MECHANICAL PROBLEM IDENTIFIED (C07) / INVESTIGATION CONCLUSIONS: CAUSE NOT ESTABLISHED (D15) / COMPONENT CODE: ROD/SHAFT (G04112) WERE SELECTED AS RELATED TO THE CUSTOMER¿S REPORTED ¿KINKED¿ ISSUE. INVESTIGATION FINDINGS: STRESS PROBLEM IDENTIFIED (C0706) / INVESTIGATION CONCLUSIONS: CAUSE NOT ESTABLISHED (D15) / COMPONENT CODE: ELECTRODE (G0201501) WERE SELECTED AS RELATED TO THE BIOSENSE WEBSTER INC. ANALYSIS FINDING OF THE ¿RING DAMAGE¿. MANUFACTURER'S REFERENCE NUMBER:(B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH LASSOSTAR NAV CIRCULAR MAPPING CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED SOME RINGS DAMAGED (I.E. DENTED AND SHARP EDGES), THE TIP SECTION WAS OBSERVED TO BE DAMAGED, AND INTERNAL COMPONENTS WERE EXPOSED. INITIALLY IT WAS REPORTED THAT THE LASSOSTAR NAV CIRCULAR MAPPING CATHETER WIRE WAS KINKED DIRECTLY OUT OF THE PACKAGE. THE CATHETER WAS REPLACED AND THE NEXT ONE WAS ALSO KINKED. WHEN THE CATHETER WAS REPLACED AGAIN, THE ISSUE RESOLVED. ALL CATHETERS WERE FROM THE SAME LOT NUMBER. NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. NO PHYSICAL DAMAGE TO THE OUTER BOX OR PACKAGING. NO PICTURES AVAILABLE. WAS NOT ABLE TO TAKE PICTURES DURING THE PROCEDURE. THE DEVICE WAS SECURED PROPERLY IN THE TRAY. NO DAMAGE TO THE DEVICE DUE TO ANY PART OF THE PACKAGING BEING DAMAGED. EVERYTHING WAS DISCARDED EXCEPT THE CATHETERS. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND PER THE EVALUATION COMPLETION ON 22-SEP-2023, A BENT WAS OBSERVED ON THE SHAFT. ADDITIONALLY, SOME RINGS WERE OBSERVED TO BE DAMAGED (I.E. DENTED AND SHARP EDGES), THE TIP SECTION WAS OBSERVED TO BE DAMAGED, AND THE INTERNAL COMPONENTS WERE EXPOSED. THIS EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE OF SOME RINGS WERE OBSERVED TO BE DAMAGED (I.E. DENTED AND SHARP EDGES), THE TIP SECTION WAS OBSERVED TO BE DAMAGED, AND THE INTERNAL COMPONENTS WERE EXPOSED ON 22-SEP-2023 AND HAVE ASSESSED THIS RETURNED CONDITION AS REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96964 LASSOSTAR NAV CIRCULAR MAPPING CATHETER CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER INC 30929201L 10846835020335

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown LASSOSTARNAV,10P,15MM DIA LOOP.