BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY

    MDR report key: 17870725 · Received October 4, 2023

    Report

    Report Number
    2029046-2023-02229
    Event Type
    Malfunction
    Date Received
    October 4, 2023
    Date of Event
    June 7, 2023
    Report Date
    October 4, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    UDI-DI
    10846835023015
    PMA / PMN Number
    K211438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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 AND FUNCTIONAL TEST OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING BWI PROCEDURES. VISUAL ANALYSIS REVEALED IN THE TRANSITION OF THE TIP WITH THE SPLINES, IT WAS FOUND BROKEN WITH EXPOSED INTERNAL PARTS. ALSO, THE INTRODUCER WAS FOUND TORN. A DIMENSIONAL TEST WAS PERFORMED, AND THE OUTER DIAMETERS OF THE DEVICE WERE FOUND WITHIN SPECIFICATIONS. THE DAMAGE ON THE TIP AND ON THE INTRODUCER SUGGESTS THAT A RESISTANCE WITH SHEATH EVENT TOOK PLACE, HOWEVER, THIS COULD NOT BE CONCLUSIVELY DETERMINED AS NO ISSUES WERE DETECTED DURING THE DIMENSIONAL INSPECTION. BASED ON THE DAMAGE OBSERVED THE ISSUE DESCRIBED BY THE CUSTOMER 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 AND NO INTERNAL ACTIONS RELATED TO THE COMPLAINT WERE FOUND DURING THE REVIEW. THE RESISTANCE ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED. THE INSTRUCTIONS FOR USE CONTAIN (IFU) THE FOLLOWING RECOMMENDATIONS: DO NOT INTRODUCE THE CATHETER INTO A GUIDING SHEATH WITH THE CATHETER¿S DISTAL SPINES FOLDED BACKWARD TOWARD THE HANDLE. 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).

    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 (B)(4). IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. NO: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH AN OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED THE TRANSITION OF THE TIP WITH THE SPLINES WAS BROKEN EXPOSING INTERNAL PARTS. IT WAS INITIALLY REPORTED THE OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY WOULD NOT ADVANCE INTO THE SL1 ABBOTT SHEATH. CALLER STATED THE PHYSICIAN HAD TO USE A DIFFERENT TYPE/BRAND OF SHEATH IN ORDER TO ADVANCE THE CATHETER. WHEN THE SHEATH AND THE CATHETER WAS REPLACED, THE ISSUE RESOLVED. THE CUSTOMER¿S REPORTED ISSUE OF RESISTANCE WITH THE SHEATH IS NOT CONSIDERED TO BE MDR REPORTABLE SINCE AN INCREASED POTENTIAL FOR PATIENT INJURY IS REMOTE. ON 13-SEP-2023, THE BWI PAL REVEALED THAT A VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THE TRANSITION OF THE TIP WITH THE SPLINES WAS BROKEN EXPOSING INTERNAL PARTS. THIS FINDING WAS REVIEWED AND ASSESSED AS AN MDR REPORTABLE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87390 OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER INC 30904792M 10846835023015

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SL1 ABBOTT SHEATH