BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI FIELDER XT PTCA GUIDE WIRE

    MDR report key: 7408158 · Received April 9, 2018

    Report

    Report Number
    3003775027-2018-00070
    Event Type
    Injury
    Date Received
    April 9, 2018
    Date of Event
    March 19, 2018
    Report Date
    March 20, 2018
    Manufacturer
    AV-ASAHI
    Product Code
    DQX
    PMA / PMN Number
    K072431
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ASAHI INTECC HAS DETERMINED THAT THE DATE RECORDED IN BLOCK B4 "DATE OF THIS REPORT" WAS ERRONEOUSLY REPORTED AS THE DATE THE REPORT WAS SUBMITTED RATHER THAN THE DATE THE INITIAL REPORTER PROVIDED THE INFORMATION ABOUT THE EVENT TO THE COMPANY. CORRECTIVE ACTION HAS BEEN TAKEN TO CLARIFY WHICH DATE SHOULD BE PROVIDED IN THE REPORT. THIS SUPPLEMENTAL REPORT IS INTENDED ONLY TO CORRECT THE DATE PROVIDED IN BLOCK B4 TO REFLECT THE DATE THE INITIAL REPORTER PROVIDED THE INFORMATION ABOUT THE EVENT TO THE COMPANY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE ANALYSIS WAS PERFORMED BY ASAHI INTECC. CO. LTD: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. DEVICE INVESTIGATION COULD NOT BE CONDUCTED AS THE DEVICE WAS NOT RETURNED, THEREFORE A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBER WERE NOT PROVIDED. BASED ON THE PROVIDED INFORMATION, IT WAS PRESUMED THAT TENSILE STRESS EXCEEDING THE PRODUCTS DESIGN LIMIT MIGHT BE INADVERTENTLY APPLIED TO THE GUIDE WIRE WHILE ITS DISTAL TIP WAS BEING TRAPPED BY THE HEAVILY CALCIFIED LESION. ALTHOUGH DEVICE INVESTIGATION OF THE SUBJECT GUIDE WIRE COULD NOT BE CONDUCTED, SINCE ALL THE SHIPPED PRODUCTS WERE INSPECTED IN THE PRODUCTION PROCESS FOR MEETING THE PRODUCT SPECIFICATIONS AND RELEASE CRITERIA, THERE WAS NO INDICATION OF A PRODUCT DEFICIENCY. THE UDI IS UNKNOWN BECAUSE THE PART NUMBER AND LOT NUMBER WERE NOT PROVIDED. THE DEVICE IS MANUFACTURED BY ASAHI (B)(4)., HOWEVER, THE MANUFACTURING SITE COULD NOT BE DETERMINED BECAUSE THE PRODUCT LOT NUMBER WAS NOT PROVIDED. ABBOTT VASCULAR DISTRIBUTES THE DEVICE AND IS RESPONSIBLE FOR MDR REPORTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, HEAVILY TORTUOUS OBTUSE MARGINAL (OM) CORONARY ARTERY. ON (B)(6) 2018, DURING REMOVAL OF A FIELDER XT ASAHI GUIDE WIRE (GW), RESISTANCE WAS NOTED WITH THE ANATOMY AND THE PHYSICIAN FELT THE WIRE MAKE A POPPING NOISE. AS THE WIRE WAS BEING ENTIRELY REMOVED THERE WAS ALSO DIFFICULTY NOTED WITH THE SHEATH. ONCE REMOVED, IT WAS NOTED THAT THE CORE OF THE GW HAD BROKEN OFF. FLUOROSCOPY WAS PERFORMED AND IT WAS CONFIRMED THAT THE CORE OF THE GW REMAINS IN THE OM LESION. ON (B)(6) 2018, PATIENT WAS SENT FOR A SURGICAL BRACHIAL CUT-DOWN SURGERY TO RETRIEVE THE BROKEN PIECE. A PORTION OF THE WIRE WAS REMOVED, BUT THE DISTAL PORTION OF THE WIRE REMAINED IN THE AORTA AND LEFT CORONARY SYSTEM. ON (B)(6) 2018, ANOTHER PORTION OF THE WIRE WAS REMOVED FROM THE AORTA VIA A SNARE DEVICE. HOWEVER, THE 3CM TIP OF THE WIRE STILL REMAINS IN THE OM LESION. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250606 ASAHI FIELDER XT PTCA GUIDE WIRE GUIDE WIRE DQX AV-ASAHI

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention