BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASAHI CORSAIR MICROCATHETER

    MDR report key: 3267590 · Received August 6, 2013

    Report

    Report Number
    3003775027-2013-00040
    Event Type
    Malfunction
    Date Received
    August 6, 2013
    Date of Event
    June 21, 2013
    Report Date
    July 12, 2013
    Manufacturer
    AV-ASAHI
    Product Code
    DQY
    PMA / PMN Number
    K083127
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE RX TREK AND ASAHI FIELDER ARE BEING FILED UNDER SEPARATE MANUFACTURING REPORT NUMBERS. THE DEVICE IS MANUFACTURED BY ASAHI INTECC. CO. LTD. MEDICAL DIVISION; HOWEVER, ABBOTT VASCULAR DISTRIBUTES THE DEVICE AND IS RESPONSIBLE FOR MDR REPORTING.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE ANALYSIS WAS PERFORMED BY ASAHI INTECC. CO. LTD: THE CORSAIR 150CM AND FIELDER XT 300CM WERE RETURNED FOR OUR INVESTIGATION. THE CORSAIR AND FIELDER XT BECAME STUCK WITH EACH OTHER BECAUSE OF THE DAMAGED TIP OF CORSAIR. THE TIP OF THE CORSAIR WAS BADLY DEFORMED AND DAMAGED, DUE TO SUPPOSEDLY COUNTERCLOCKWISE ROTATION, HOWEVER; NO TRACE OF SEPARATION WAS OBSERVED WITH THE TIP. THE FIELDER XT GUIDE WIRE WAS ALSO DAMAGED WITH PARTIAL BREAKAGE OF THE COIL WIRE, MOVING BACK OF THE DEFORMED COIL WIRE, OVER THE COIL AND PLASTIC JACKET. HOWEVER, NO SEPARATION OF THE PART WAS INFERRED. WITH THE PROVIDED INFORMATION AND THE OUTCOME OF INSPECTION OF THE RETURNED DEVICES, IT IS PRESUMED THAT THE CORSAIR AND FIELDER XT BECAME STUCK WITH EACH OTHER DUE TO THE ABRASIVE FRICTION BY THE TARGET LESION. THE ROTATIONAL MANIPULATION APPLIED TO THE DEVICES, MIGHT HAVE AGGRAVATED THE CONDITION OF BEING STUCK, RESULTING IN PARTIAL DAMAGE OF THE DEVICES. THE INSTRUCTIONS FOR USE (IFU) OF THE CORSAIR MICROCATHETER DESCRIBES: DO NOT USE IN ADVANCED CALCIFIED LESIONS. ALSO: IF ANY RESISTANCE OR SOMETHING ABNORMAL IS FELT WHEN OPERATING THIS PRODUCT, DO NOT CONTINUE THE OPERATION WHILE THE CAUSES ARE UNCLEAR. IF IT IS SUSPECTED THAT THE PRODUCT IS NOT OPERATING CORRECTLY, AVOID EXCESSIVE MANIPULATION. INVESTIGATION OF THE PRODUCTION RECORD COULD NOT BE CONDUCTED AS NO LOT INFORMATION WAS PROVIDED. THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON APPROXIMATELY (B)(6) 2013, DURING A HEAVILY CALCIFIED CHRONIC TOTAL OCCLUSION INTERVENTION IN THE RIGHT CORONARY ARTERY, VIA RETROGRADE APPROACH, WHILE WORKING THEIR WAY THROUGH THE LESION, THE CORSAIR MICROCATHETER AND THE FIELDER XT BECAME STUCK TOGETHER AND HAD TO BE REMOVED AS ONE UNIT. ADDITIONALLY, DURING THE PROCEDURE, WHILE ATTEMPTING TO OPEN THE LESION WITH AN RX TREK BALLOON DILATATION CATHETER, THE SHAFT SEPARATED. ANOTHER BALLOON WAS TAKEN TO THE SEPARATED SHAFT ENABLING REMOVAL OF THE SEPARATED DEVICE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. THE PATIENT IS SCHEDULED TO RETURN FOR ADDITIONAL INTERVENTION TO THE LESION. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367844 ASAHI CORSAIR MICROCATHETER SUPPORT CATHETER DQY AV-ASAHI

    Patients

    Seq Age Sex Outcome Treatment
    1 FIELDER XT