BEUDAMED
    FDA Adverse Event Injury Summary report: N

    METACROSS OTW PTA BALLOON DILATATION CATHETER

    MDR report key: 8908728 · Received August 19, 2019

    Report

    Report Number
    3002808904-2019-00024
    Event Type
    Injury
    Date Received
    August 19, 2019
    Date of Event
    July 23, 2019
    Report Date
    July 29, 2019
    Manufacturer
    KANEKA CORPORATION
    Product Code
    LIT
    PMA / PMN Number
    K152080
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONCERNED DEVICE "METACROSS OTW" IS A OVER-THE WIRE (OTW) TYPE PTA BALLOON DILATATION CATHETER COMPATIBLE TO 0.035" GUIDEWIRE (GW). "METACROSS OTW" IS DISTRIBUTED IN THE US UNDER 510(K) # K152080. THE DEVICE HISTORY RECORDS (DHR) OF THE DEVICE CONCERNED WAS REVIEWED: THE PRODUCTION LOT, TO WHICH THE DEVICE CONCERNED BELONGS, PASSED ALL IN-PROCESS INSPECTIONS FOR EVERY PRODUCT, AND THE FINISHED PRODUCT INSPECTIONS ON REPRESENTATIVE SAMPLES BASED ON SAMPLING PLAN. NO NONCONFORMITY OR ABNORMALITY IN THE MANUFACTURING PROCESSES OF THE DEVICE CONCERNED WAS FOUND. PROBABLE CAUSE(S) AND OUR COMMENT: WE SPECULATE THE REPORTED SITUATION AS FOLLOWS: WHEN THE CATHETER WAS ATTEMPTED TO BE RETRIEVED THROUGH THE SHEATH, AS THE FRICTIONAL RESISTANCE BETWEEN THE BALLOON AND THE INNER WALL OF THE SHEATH INCREASED, THE CATHETER COULD NOT BE RETRIEVED. NO NONCONFORMITY OR ABNORMALITY IN THE MANUFACTURING PROCESSES OF THE DEVICE CONCERNED WAS FOUND, AND ACCORDINGLY, WE DETERMINE THAT THE EVENT REPORTED WAS CAUSED BY NOT ANY DEFECT OF THE DEVICE BUT THE USER'S HANDLING ISSUES.

    Description of Event or Problem · 1

    DR PUT THE METACROSS BALLOON INTO PERCUTANEOUS HUMORAL POSITION; WHEN HE WANTED TO REMOVE THE BALLOON, IT GOT STUCK IN THE INTRODUCER THAT WAS IN THE HUMORAL ARTERY. DR (B)(6) WAS FORCED TO MAKE AN INCISION IN THE ARM AND OPEN THE ARTERY TO REMOVE THE BALLOON FROM THE INTRODUCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699813 METACROSS OTW PTA BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT KANEKA CORPORATION SP098102

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention