BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTARAY MAPPING CATHETER

    MDR report key: 19389018 · Received May 23, 2024

    Report

    Report Number
    2029046-2024-01699
    Event Type
    Malfunction
    Date Received
    May 23, 2024
    Date of Event
    March 8, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    MTD
    UDI-DI
    10846835021141
    PMA / PMN Number
    K193237
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION DETAILS: THE PRODUCT WAS RETURNED TO BIOSENSE WEBSTER INC (BWI) FOR EVALUATION AND THE EVALUATION HAS BEEN COMPLETED. A VISUAL INSPECTION OF THE RETURNED DEVICE WAS PERFORMED FOLLOWING BWI PROCEDURES. VISUAL ANALYSIS REVEALED THAT THE SPLINE ¿F¿ WAS DETACHED, AND ELECTRODE #F1 WAS MISSING. MICROSCOPIC EXAMINATION WAS PERFORMED AND ELONGATION WAS OBSERVED, CONFIRMING EXCESSIVE FORCE. DUE TO THE CONDITION OF THE DEVICE FURTHER ANALYSIS IN CARTO 3 SYSTEM COULD NOT BE PERFORMED. THE SPLINE CONDITION CAN BE RELATED TO THE ISSUES DESCRIBED BY THE CUSTOMER. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO INTERNAL ACTIONS WERE IDENTIFIED. THE DAMAGE ON THE SPLINE COULD BE RELATED TO THE ELECTRICAL ISSUE REPORTED BY THE CUSTOMER, THEREFORE, THE CUSTOMER COMPLAINT WAS CONFIRMED. THE POTENTIAL CAUSE OF FAILURE COULD BE RELATED TO THE MANIPULATION OF THE DEVICE DURING OR AFTER PROCEDURE; HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING WARNING STATED IN THE CARTO 3 SYSTEM MANUAL: EXCESSIVE BENDING OR KINKING OF THE CATHETER SHAFT OR SPINES MAY DAMAGE LEAD WIRES AND CAUSE LOSS OF ELECTRODE FUNCTION. DO NOT USE EXCESSIVE FORCE TO ADVANCE OR WITHDRAW THE CATHETER THROUGH THE GUIDING SHEATH IF RESISTANCE IS ENCOUNTERED. PRIOR TO REMOVING OR REPOSITIONING THE CATHETER, USE DIRECT IMAGING GUIDANCE SUCH AS FLUOROSCOPY OR ULTRASOUND TO CONFIRM THAT THE SPINE ASSEMBLY IS NOT ENTANGLED WITH ANOTHER CATHETER OR WITH AN ANATOMICAL STRUCTURE. EXERCISE CAUTION WHEN MANEUVERING THE CATHETER NEAR THE VALVULAR APPARATUS TO AVOID ENTANGLEMENT OR ENTRAPMENT WHICH MAY RESULT IN THE NEED FOR SURGICAL INTERVENTION. AS PART OF BIOSENSE WEBSTER'S 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 REF. # (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A OCTARAY MAPPING CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED SPLINE ¿F¿ WAS DETACHED, AND ELECTRODE #F1 WAS MISSING. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT THE OCTARAY MAPPING CATHETER DISPLAYED A NOISY ELECTRODE. THE CABLE WAS EXCHANGED WITHOUT RESOLUTION. THE CATHETER WAS EXCHANGED AND THE NOISE RESOLVED, CASE CONTINUED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE. THE CUSTOMER'S REPORTED NOISE ISSUE IS NOT CONSIDERED TO BE MDR REPORTABLE SINCE THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH TO THE OPERATOR OR PATIENT IS REMOTE. ON (B)(6) 2024, THE BWI PAL REVEALED THAT A VISUAL INSPECTION OF THE RETURNED DEVICE FOUND SPLINE ¿F¿ WAS DETACHED, AND ELECTRODE #F1 WAS MISSING. THIS FINDING WAS REVIEWED AND WAS ASSESSED AS AN MDR REPORTABLE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623437 OCTARAY MAPPING CATHETER CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY MTD BIOSENSE WEBSTER INC 31199403L 10846835021141

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNKNOWN CABLE