BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 12467096 · Received September 14, 2021

    Report

    Report Number
    0002090040-2021-00032
    Event Type
    Malfunction
    Date Received
    September 14, 2021
    Date of Event
    June 8, 2021
    Report Date
    September 14, 2021
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS PHOENIX
    Product Code
    NLH
    UDI-DI
    00885825007355
    PMA / PMN Number
    K052603
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS FOR EVALUATION. UPON INSPECTION OF THE RECEIVED COMPLAINT DEVICE, A BEND WAS IDENTIFIED 2 CM FROM THE DISTAL TIP; WHICH IS DISTAL TO THE TRANSITION POINT. THE HANDLE, STEERING KNOB, AND CONNECTOR PINS APPEAR TO BE INTACT. THE DEVICE WAS EVALUATED. THE DEVICE DID NOT MEET THE CURVE OR PLANARITY SPECIFICATION. A REVIEW OF THE DHR SUPPORTS THAT THE DEVICE MET ALL INSPECTION AND TEST CRITERIA PRIOR TO RELEASE FROM STRYKER. THE REPORTED EVENT COULD BE ATTRIBUTED TO MISHANDLING SUBSEQUENT TO DISTRIBUTION, INCLUDING SHIPPING/STORAGE CONDITIONS OR IMPROPER MANIPULATION OF THE CATHETER. THE INSTRUCTION FOR USE (IFU) STATE: INSPECT THE CATHETER FOR OVERALL CONDITION AND PHYSICAL INTEGRITY. DO NOT USE THE CATHETER IF ELECTRODES APPEAR LOOSE OR IF ANY DAMAGE IS NOTED. IF SUCH PROBLEMS EXIST, RETURN THE CATHETER AND PACKAGING TO STRYKER SUSTAINABILITY SOLUTIONS. CONNECT THE CATHETER TO THE CORRESPONDING CABLE CONNECTOR. CONNECT THE CABLE TO THE CORRECT ELECTRONIC EQUIPMENT FOR RECORDING AND/OR SENSING. OBSERVE POLARITY OF PROXIMALLY LOCATED CONNECTOR PINS OF THE INTERFACE CABLE WHEN CONNECTING TO THE ELECTRONIC EQUIPMENT. ISOLATE ANY UNUSED CONNECTOR PINS TO REDUCE DEVELOPMENT OF ACCIDENTAL CURRENT PATHWAYS TO THE HEART. FOLLOW A SUITABLE ELECTROPHYSIOLOGY STUDY PROTOCOL. DO NOT AUTOCLAVE CATHETER. DO NOT USE FOR ELECTRICAL ABLATION. AVOID EXCESSIVE CONTACT OF HANDPIECE WITH FLUIDS, AS THIS COULD ADVERSELY AFFECT THE ELECTRICAL PERFORMANCE OF THE CATHETER. DIAGNOSTIC EP CATHETERS ARE NOT RECOMMENDED FOR LONG TERM PACING. THE REPORTED EVENT WILL CONTINUE TO BE MONITORED THROUGH POST-MARKET SURVEILLANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PHYSICIAN WAS ATTEMPTING TO USE A REPROCESSED ABBOTT LIVEWIRE DIAGNOSTIC EP CATHETER DURING THE PROCEDURE, BUT REALIZED THAT THE CATHETER WAS NOT DEFLECTING CORRECTLY, AND THERE WAS A KINK/BEND BETWEEN SOME OF THE ELECTRODES ON THE CATHETER THAT PREVENTS THE CATHETER FROM RETURNING TO A STRAIGHT POSITION. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS LESS THAN 5 MINUTES WHILE STAFF WENT TO RETRIEVE A NEW REPLACEMENT CATHETER FROM THE STOREROOM. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1365852 NA CATHETER, RECORDING, ELECTRODE, REPROCESSED NLH STRYKER SUSTAINABILITY SOLUTIONS PHOENIX 401932 4379833 00885825007355

    Patients

    Seq Age Sex Outcome Treatment
    1