BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY

    MDR report key: 19282086 · Received May 9, 2024

    Report

    Report Number
    2029046-2024-01533
    Event Type
    Malfunction
    Date Received
    May 9, 2024
    Date of Event
    January 31, 2024
    Report Date
    June 5, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    UDI-DI
    10846835025828
    PMA / PMN Number
    K230253
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON 09-MAY-2024, THE MANUFACTURE AND EXPIRATION DATES HAVE BEEN PROVIDED. THEREFORE, FIELDS D4. EXPIRATION DATE AND H4. DEVICE MANUFACTURE DATE HAVE BEEN POPULATED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    E 1. INITIAL REPORTER PHONE : (B)(6) THE DEVICE WAS RETURNED TO BIOSENSE WEBSTER FOR EVALUATION. A VISUAL INSPECTION, MAGNETIC SENSOR FUNCTIONALITY AND ELECTRICAL TESTS OF THE RETURNED DEVICE WERE PERFORMED IN ACCORDANCE WITH BWI PROCEDURES. VISUAL ANALYSIS OF THE RETURNED DEVICE REVEALED SOME ELECTRODES LIFTED ON THE TIP AREA. IN ADDITION, A WRINKLED CONDITION WAS OBSERVED NEXT TO ELECTRODES A4, A5 AND A6. A MAGNETIC SENSOR FUNCTIONALITY TEST WAS PERFORMED, AND THE DEVICE FAILED THE TEST SINCE ELECTRODE A5 AND A6 WERE OBSERVED BLACK. AN ELECTRICAL TEST WAS PERFORMED, AND THE DEVICE FAILED, NO ELECTRICAL READINGS WERE OBSERVED ON ELECTRODE A5 AND A6 DUE TO AN OPEN CIRCUIT ON THE TIP AREA. A MANUFACTURING RECORD WAS PERFORMED FOR THE FINISHED DEVICE AND NO NON-CONFORMANCE WAS FOUND DURING THE REVIEW. THE VISUALIZATION ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED. THE POTENTIAL CAUSE OF THE OPEN CIRCUIT CANNOT BE DETERMINED. THE POTENTIAL CAUSE OF THE WRINKLES AND LIFTED ELECTRODES ON THE TIP COULD BE RELATED TO THE MANIPULATION OF THE DEVICE DURING THE PROCEDURE; HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. THE INSTRUCTIONS FOR USE (IFU) CONTAIN THE FOLLOWING RECOMMENDATIONS: DO NOT INTRODUCE THE CATHETER INTO A GUIDING SHEATH WITH THE CATHETER¿S SPINES FOLDED BACK TOWARD THE HANDLE. COLLAPSE THE SPINES TOGETHER USING THE INSERTION TUBE PRIOR TO INSERTION. THE CATHETER IS RECOMMENDED FOR USE WITH AN 8.5 F GUIDING SHEATH BECAUSE THE SPINES MAY BE DAMAGED IF USED WITH A SHEATH THAT IS NOT COMPATIBLE. 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. 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. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA CARDIAC ABLATION PROCEDURE WITH A OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED ELECTRODES LIFTED ON THE TIP AREA. INITIALLY, IT WAS REPORTED THAT DURING RIGHT ATRIUM (RA) MAPPING, WHEN USING OPTRELL, LEAKAGE-CURRENT VECTOR (LCV) WAS NOT DISPLAYED. WHEN SELECTING TRUEREF, AN ERROR MESSAGE WAS DISPLAYED STATING THAT IT COULD NOT BE USED AND COULD NOT SELECT WAVEFRONT. THE ISSUE WAS NOT RESOLVED AFTER RECONNECTING, REPLACING THE CABLE, AND REPLACING THE CATHETER. THE PROCEDURE WAS CONTINUED WITHOUT USING LCV AND WAVEFRONT. AFTER THE PROCEDURE, OPENED THE STUDY WITH THE SAME TEMPLATE, AND VALIDATED WITH CONNECTING THE OPTRELL THAT WAS USED IN THE PROCEDURE. THE ISSUE DID NOT OCCUR AND SO IT WAS NON-REPRODUCIBLE. RECREATED ALL THE TEMPLATE AND CONDUCTED. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT CONSEQUENCE. THE VISUALIZATION ISSUE WAS ASSESSED AS NON MDR REPORTABLE. THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH TO THE OPERATOR OR PATIENT WAS REMOTE. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE AND PER THE EVALUATION COMPLETION ON (B)(6) 2024, THERE WERE ELECTRODES WRINKLED AND LIFTED ON THE TIP AREA. THIS WAS ASSESSED AS MDR REPORTABLE WITH AN AWARENESS DATE OF 13-APR-2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751777 OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER INC 31178901M 10846835025828

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown JPN CARTO 3 SYSTEM| UNK CABLE| UNK CABLE