BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET XL 360 SOFT 12MM X 45CM

    MDR report key: 9420615 · Received December 5, 2019

    Report

    Report Number
    3008881809-2019-00376
    Event Type
    Malfunction
    Date Received
    December 5, 2019
    Date of Event
    November 11, 2019
    Report Date
    December 5, 2019
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    HCG
    UDI-DI
    04546540711533
    PMA / PMN Number
    K153658
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, PHYSICAL AS WELL AS FUNCTIONAL TESTING COULD NOT BE PERFORMED. THE REPORTED ISSUE IS COVERED IN THE DEVICE DIRECTIONS FOR USE. THE RISK OF THE REPORTED EVENT IS DOCUMENTED IN THE RISK DOCUMENTATION AND THERE ARE CURRENT CONTROLS TO MITIGATE THE RISK OF THE AS REPORTED EVENT. INFORMATION AVAILABLE INDICATED THAT THE DEVICE WAS CONFIRMED TO BE IN GOOD CONDITION PRIOR TO USE. THE PRODUCT WAS NOT RETURNED, HOWEVER, ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE USER INDICATED THAT THE DEVICE WAS USED WITH AN INCOMPATIBLE MICROCATHETER. AS PER THE TARGET DFU: ¿TARGET DETACHABLE COILS ARE COMPATIBLE WITH STRYKER NEUROVASCULAR 2-TIP MARKER MICROCATHETERS (MIN. INTERNAL DIAMETER 0.41 MM [0.016 IN], MAX. INTERNAL DIAMETER 0.48 MM [0.019 IN]). THE MEDICAL DEVICE USED TO DELIVER THE COIL WAS NOT IN THE DFU SPECIFICATIONS. THEREFORE, AN ASSIGNABLE CAUSE OF USER ERROR HAS BEEN ASSIGNED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE THE SUBJECT COIL PREMATURELY DETACHED WITHIN THE (NON-STRYKER) CATHETER INSIDE THE PATIENT. THE COIL WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENTS MEDICAL CONDITION WAS GOOD. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1213317 TARGET XL 360 SOFT 12MM X 45CM DEVICE, NEUROVASCULAR EMBOLIZATION HCG STRYKER NEUROVASCULAR CORK 19909361 04546540711533

    Patients

    Seq Age Sex Outcome Treatment
    1