BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTARAY MAPPING CATHETER

    MDR report key: 17401765 · Received July 26, 2023

    Report

    Report Number
    2029046-2023-01605
    Event Type
    Malfunction
    Date Received
    July 26, 2023
    Date of Event
    May 4, 2023
    Report Date
    July 26, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    MTD
    UDI-DI
    10846835021158
    PMA / PMN Number
    K193237
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION DETAILS: THE DEVICE WAS RETURNED TO BIOSENSE WEBSTER INC (BWI) FOR EVALUATION AND THE EVALUATION HAS BEEN COMPLETED. A VISUAL INSPECTION, ELECTRICAL, AND DEFLECTION TEST OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING BWI PROCEDURES. VISUAL INSPECTION WAS PERFORMED, AND THE SPLINES WERE OBSERVED BENT, ONE SPLINE WAS OBSERVED WITH SOME ELECTRODES LIFTED. THEN, A DEFLECTION AND ELECTRICAL TEST WERE PERFORMED, AND NO ISSUES WERE OBSERVED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT AND INTERNAL ACTIONS RELATED TO THE COMPLAINT WERE FOUND DURING THE REVIEW. THE ELECTRICAL AND DEFLECTION ISSUES REPORTED BY THE CUSTOMER WERE NOT CONFIRMED HOWEVER, THE SPLINE DAMAGE WAS CONFIRMED. THE POTENTIAL CAUSE OF THE DAMAGE COULD BE RELATED TO THE USAGE OF THE DEVICE DURING PROCEDURE HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING RECOMMENDATION: DO NOT INTRODUCE THE CATHETER INTO A GUIDING SHEATH WITH THE CATHETER¿S DISTAL SPINES FOLDED BACK TOWARD THE HANDLE. COLLAPSE THE SPINES TOGETHER USING THE INSERTION TUBE PRIOR TO INSERTION. AS PART OF BIOSENSE WEBSTER'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. EXPLANATION OF CODES: INVESTIGATION FINDINGS: MECHANICAL PROBLEM IDENTIFIED (C07) / INVESTIGATION CONCLUSIONS: CAUSE NOT ESTABLISHED (D15) / COMPONENT CODE: TIP (G04129) WERE SELECTED AS RELATED TO THE ISSUE OF BENT IN THE SPLINES. INVESTIGATION FINDINGS: STRESS PROBLEM IDENTIFIED (C0706) / INVESTIGATION CONCLUSIONS: CAUSE NOT ESTABLISHED (D15) / COMPONENT CODE: ELECTRODE (G0201501) WERE SELECTED AS RELATED TO THE ISSUE OF LIFTED ELECTRODES. INVESTIGATION FINDINGS: NO DEVICE PROBLEM FOUND (C19) / INVESTIGATION CONCLUSIONS: NO PROBLEM DETECTED (D14) WERE SELECTED AS RELATED TO THE CUSTOMER'S REPORTED NOISE AND DEFLECTION ISSUES. 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 AN OCTARAY MAPPING CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED ELECTRODE DAMAGE. IT WAS INITIALLY REPORTED BY THE CUSTOMER THERE WAS NOISE ON ELECTRODES E 1 & 2 OF THE CATHETER DISPLAYED ON THE CARTO 3 SYSTEM AND THE RECORDING SYSTEM WHEN THE CATHETER WAS INSERTED INTO THE BODY. THE CALLER STATED THAT THE DEFLECTION OF THE CATHETER WAS NOT WORKING APPROPRIATELY AND THAT ONE OF THE SPLINES OF THE CATHETER APPEARED TO BE BENT. THE CALLER STATED THAT THE CATHETER WAS UNABLE TO BE FULLY DEFLECTED. THEY REPLACED THE CATHETER, AND THE ISSUE WAS RESOLVED. THERE WAS NO PATIENT CONSEQUENCE. THE CUSTOMER¿S REPORTED ISSUES OF NOISE, DEFLECTION AND BENT ARE NOT CONSIDERED TO BE MDR REPORTABLE SINCE THE POTENTIAL RISK THAT THESE COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS DETERIORATION IN STATE OF HEALTH IS REMOTE. ON 3-JUL-2023, THE BWI PAL REVEALED THAT A VISUAL INSPECTION OF THE RETURNED DEVICE FOUND ONE OF THE SPLINES WAS OBSERVED WITH SOME ELECTRODES LIFTED. THIS FINDING HAS BEEN REVIEWED AND ASSESSED AS AN MDR REPORTABLE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1481484 OCTARAY MAPPING CATHETER CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY MTD BIOSENSE WEBSTER INC 30839457L 10846835021158

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown CARTO 3 SYSTEM| OCTA,LNG,48P,2-5-2-5-2,F-CURVE| UNKNOWN RECORDING SYSTEM