BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 16057562 · Received December 27, 2022

    Report

    Report Number
    0002090040-2022-00003
    Event Type
    Injury
    Date Received
    December 27, 2022
    Date of Event
    September 1, 2018
    Report Date
    December 27, 2022
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS PHOENIX
    Product Code
    NLH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION TO STRYKER SUSTAINABILITY SOLUTIONS FOR EVALUATION. DEVICE DISPOSITION WAS UNABLE TO BE CONFIRMED AS NO CUSTOMER CONTACT INFORMATION HAS BEEN PROVIDED. AS THE DEVICE WAS NOT RETURNED FOR EVALUATION, AND NO IDENTIFIERS WERE REPORTED, IT WAS UNABLE TO BE CONFIRMED IF THE DEVICE WAS MANUFACTURED BY STRYKER SUSTAINABILITY SOLUTIONS. AS THE DEVICE WAS NOT RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS, EVALUATION WAS UNABLE TO BE PERFORMED. NO DEVICE INFORMATION WAS REPORTED, AND THE CUSTOMER DID NOT REPORT LOT NUMBER OR SERIAL NUMBER INFORMATION. THEREFORE, THE DEVICE HISTORY RECORD (DHR) WAS UNABLE TO BE VERIFIED. THE REPORTED EVENT COULD BE ATTRIBUTED TO: DEVICE MISHANDLING BY USER, USER IMPROPERLY MANIPULATES CATHETER INTRODUCER SHEATH , POOR FIT OF COMPONENTS BETWEEN SHEATH, DILATOR, GUIDEWIRE, USER IMPROPERLY FITS DILATOR TO SHEATH, POOR FIT OF COMPONENTS, INCOMPATIBLE CATHETER IS USED , POOR FIT OF CATHETER INTRODUCER SHEATH COMPONENTS, EXCESSIVE FORCE APPLIED TO DEVICE, SHIPPING/ HANDLING DAMAGE. THE INSTRUCTIONS FOR USE (IFU) STATE: STORE IN A COOL DRY PLACE. ALL COMPONENTS SHOULD BE CAREFULLY INSPECTED BEFORE USE. IF THE PACKAGE OR ITEMS APPEAR TO BE DAMAGED OR DEFECTIVE, DO NOT USE. PRIOR TO ADVANCING THE DILATOR OR ANY OTHER COMPONENT, ALWAYS OBSERVE ACCEPTABLE HEMODYNAMICS. DO NOT ATTEMPT TO INSERT A CATHETER HAVING A BODY SIZE OR DISTAL TIP LARGER THAN THE INDICATED INTRODUCER SIZE. DO NOT REMOVE CATHETER OR DILATOR RAPIDLY AS DAMAGE TO THE BACK BLEED VALVE MAY OCCUR. INSPECT THE AGILIS NXT STEERABLE INTRODUCER FOR OVERALL CONDITION AND PHYSICAL INTEGRITY. DO NOT USE THE AGILIS NXT STEERABLE INTRODUCER IF ANY DAMAGE IS NOTED. RETURN THE INTRODUCER AND PACKAGING TO STRYKER SUSTAINABILITY SOLUTIONS IF IT IS NOT IN ACCEPTABLE CONDITION FOR THE PROCEDURE. AS THE DEVICE WAS NOT RETURNED AND NO CUSTOMER CONTACT INFORMATION AVAILABLE, NEITHER THE FAILURE MODE NOR THE MANUFACTURER COULD BE CONFIRMED. THE REPORTED EVENT WILL CONTINUE TO BE MONITORED THROUGH POST MARKET SURVEILLANCE. SHOULD THE DEVICE BECOME AVAILABLE FOR RETURN, THE INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 0

    IT WAS REPORTED A GUIDEWIRE DISLODGED FROM THE DEVICE, AN AGILIS NXT STEERABLE INTRODUCER, DURING AN ATRIAL FLUTTER AND ATRIAL FIBRILLATION ABLATION PROCEDURE PERFORMED IN (B)(6) 2018. THE GUIDEWIRE REMAINED INSIDE THE PATIENT WHICH REQUIRED SUBSEQUENT OPEN-HEART SURGERY TO REMOVE IT. NO CUSTOMER CONTACT INFORMATION WAS PROVIDED. NO INFORMATION WAS PROVIDED REGARDING PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2653961 NA CATHETER, RECORDING, ELECTRODE, REPROCESSED NLH STRYKER SUSTAINABILITY SOLUTIONS PHOENIX

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention