BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QAPEL WAHOO SELECTFLEX 072 NEUROVASCULAR ACCESS SYSTEM

    MDR report key: 12506899 · Received September 20, 2021

    Report

    Report Number
    MW5104101
    Event Type
    Malfunction
    Date Received
    September 20, 2021
    Date of Event
    September 13, 2021
    Report Date
    September 17, 2021
    Manufacturer
    QAPEL MEDICAL, INC.
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WE NOTICED SUBOPTIMAL APPOSITION OF THE STENT AT THE DISTAL END AND INTRODUCED A TRANSFORM 7X7MM BALLOON ALONG WITH THE TRAXCESS MICROWIRE. DURING THE INTRODUCTION OF THE MICROCATHETER, WE NOTICED THERE WAS A SECOND RADIO-OPAQUE MARKER AT THE TIP OF THE WAHOO JUST AS THE MICROWIRE WAS ABOUT TO REACH THE END OF THE WAHOO TIP. HOWEVER, BY THEN, IT WAS TOO LATE AS THE MICROWIRE GENTLY TOUCHED THE RADIO-OPAQUE MARKER AND IT TRAVELLED DISTALLY INTO THE LEFT DISTAL PCA. IT WAS AT THIS TIME THAT WE CHECKED THE PHENOM PLUS CATHETER AND NOTED THAT THE TIP WAS SHEARED OFF. HOWEVER, GIVEN THE DISTAL LOCATION OF THE CURRENT MARKER TIP LOCATION, AND IT DOES NOT APPEAR TO BE OCCLUSIVE. REPEAT ANGIOGRAM DID NOT SHOW THROMBOSIS. WE FELT THAT IT WOULD BE SAFER TO LEAVE IT AS IT IS. FDA SAFETY REPORT IDS# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1400596 QAPEL WAHOO SELECTFLEX 072 NEUROVASCULAR ACCESS SYSTEM CATHETER, PERCUTANEOUS DQY QAPEL MEDICAL, INC. SF7072-105 FG210406-01
    1400597 PHENOM PLUS CATHETER CATHETER, PERCUTANEOUS DQY MEDTRONIC / MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR FG19120-1030-1S 222009886

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other