BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EP DIAGNOSTIC CATHETER EP XT STEERABLE DECAPOLAR LARGE 4.0

    MDR report key: 10627984 · Received October 5, 2020

    Report

    Report Number
    2134070-2020-00011
    Event Type
    Malfunction
    Date Received
    October 5, 2020
    Date of Event
    September 1, 2020
    Report Date
    September 8, 2020
    Manufacturer
    STERILMED, INC.
    Product Code
    NLH
    UDI-DI
    10888551013284
    PMA / PMN Number
    K051220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCOUNT PROVIDED A SINGLE PHOTO. THE PHOTOGRAPH SHOWS THE TIP OF AN EP CATHETER AND A PORTION OF THE SHAFT, AND WHAT APPEARS TO POTENTIALLY BE A FOREIGN OBJECT, POSSIBLY ORGANIC IN NATURE. NO STERILMED PACKAGING CAN BE SEEN NOR IS A CATHETER ID TAG SEEN. THE DEVICE MODEL, AND WHETHER IT IS A REPROCESSED DEVICE CANNOT BE VERIFIED FROM THE PHOTO. NO PHYSICAL DAMAGE TO THE TIP OF THE CATHETER IN THE FORM OF SPLIT OPEN CATHETER SHAFT OR CUTS TO THE CATHETER MATERIAL CAN BE SEEN. LOT NUMBER 2112257 WAS REPORTED. NO CATHETER ID HAS BEEN SUPPLIED BY THE HOSPITAL, AND AS SUCH, THE PRECISE EP CATHETER LISTED ON THE DEVICE HISTORY RECORD (DHR), AND THE NUMBER OF REPROCESSING CYCLES THAT THE DEVICE HAS UNDERGONE IS UNCERTAIN. WITHOUT THE CATHETER ID TAG, IT ALSO CANNOT BE CONFIRMED THAT THE EP CATHETER WAS LISTED ON THE LOT. A REVIEW OF THE DHR SHOWS THAT THE DEVICES PASSED ALL VISUAL CRITERIA BEFORE BEING SHIPPED TO THE CUSTOMER, AS WELL AS PASSING ALL OF THE ELECTRICAL TESTING PRIOR TO SHIPMENT. A MANUFACTURING RECORD EVALUATION WAS CONDUCTED FOR LOT 2112257 WITH NO NON-CONFORMANCES IDENTIFIED. AS THE ACCOUNT NOTED THAT THE OBJECT WAS ATTACHED TO THE TIP AFTER THE CASE, IT CANNOT BE CONFIRMED THAT THE EP CATHETER WAS THE SOURCE OF THE DEBRIS OR OBJECT IN QUESTION INSTEAD OF THE PATIENT ITSELF. THE MATERIAL THAT COMPRISES THE UNIDENTIFIED DEBRIS DOES NOT SEEM TO SHINE OR REFLECT LIGHT TO THE SAME DEGREE THAT THE PLATINUM IN THE ELECTRODES ON THE EP CATHETER TIP DOES. THIS DOES SEEM TO INDICATE THAT THE DEBRIS MAY BE ORGANIC IN NATURE AND LIKELY ATTACHED TO THE TIP OF THE CATHETER WHEN THE DEVICE WAS REMOVED FROM THE PATIENT. EP CATHETERS ARE VISUALLY EXAMINED UNDER MAGNIFICATION FOR ANY SCRATCHES, GLUE SEPARATION, DEFORMATION, PITTING AND FOREIGN DEBRIS WHICH COULD SCRATCH OR INJURE THE PATIENT. BASED SOLELY ON THE PHOTO, NO FINDINGS CAN BE DETERMINED, THUS THE ACCOUNT'S COMPLAINT COULD NOT BE CONFIRMED AS ORIGINATING FROM THE EP CATHETER. WE COULD NOT CONFIRM THE REPORTED ISSUE BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RECEIVED FOR EVALUATION. AS THE DEVICE WAS NOT RETURNED FOR EVALUATION THE VISUAL AND FUNCTIONAL INSPECTIONS COULD NOT BE PERFORMED. PER INSTRUCTIONS FOR USE FOR STERILMED REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS, ¿INSPECT PACKAGE AND PRODUCT AND DO NOT USE THE DEVICE IF DAMAGE IS NOTED OR STERILITY APPEARS TO BE COMPROMISED. REMOVE CATHETER FROM PACKAGE USING APPROPRIATE STERILE TECHNIQUE.¿ THERE WAS NO REPORT OF THE DEVICE HAVING ANY OBSERVED FOREIGN MATERIAL PRIOR TO REMOVAL FROM THE PACKAGE, INTRODUCTION INTO THE FIELD AND USE ON PATIENT. THE OBSERVATION WAS NOTED POST-OP. THERE IS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A REPROCESSING ISSUE. MANUFACTURER'S REF. NO: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE WITH A EP DIAGNOSTIC CATHETER EP XT STEERABLE DECAPOLAR LARGE 4.0 AND AFTER THE PROCEDURE, AN UNKNOWN MATERIAL WAS ATTACHED TO THE TIP. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1092331 EP DIAGNOSTIC CATHETER EP XT STEERABLE DECAPOLAR LARGE 4.0 CATHETER, RECORDING, ELECTRODE, REPROCESSED NLH STERILMED, INC. BAR201007 2112257 10888551013284

    Patients

    Seq Age Sex Outcome Treatment
    1