BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI CONFIANZA PRO 8-20

    MDR report key: 5576680 · Received April 14, 2016

    Report

    Report Number
    3003775027-2016-00058
    Event Type
    Injury
    Date Received
    April 14, 2016
    Date of Event
    January 29, 2016
    Report Date
    September 23, 2016
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    DQX
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THIS REPORT IS SOLD ONLY OUTSIDE THE USA, BUT IS SIMILAR IN STRUCTURE AND CONSTRUCTION AS A CURRENTLY MARKETED DEVICE, ASTATO XS 20 (K103057), THOUGH THE INDICATIONS FOR USE ARE DIFFERENT. THE REPORTED EVENT IS RELATED TO THE USE OF THE GUIDEWIRE IN A CORONARY APPLICATION, WHEREAS THE US MARKETED DEVICE IS CLEARED FOR PERIPHERAL APPLICATIONS ONLY. DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT. THE DEVICE WAS NOT RETURNED FOR OUR INVESTIGATION. LOT HISTORY REVIEW COULD NOT BE PERFORMED AS NO LOT INFORMATION WAS AVAILABLE. SINCE ALL THE SHIPPED PRODUCTS ARE INSPECTED IN THE PRODUCTION PROCESS FOR MEETING THE PRODUCT SPECIFICATIONS AND RELEASE CRITERIA, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. REPORTED EVENT OF REMOVAL DIFFICULTY IS DEEMED TO BE IN RELATION WITH THE ANATOMICAL CONDITION OF THE LESION, AND THE DAMAGE TO THE COIL IS SUPPOSED TO THE FORCE THAT WORKED TO THE DEVICE DURING USE. IFU DESCRIBES "IF ANY RESISTANCE IS FELT DUE TO GUIDEWIRE BEING TRAPPED WHILE OPERATING THE GUIDEWIRE IN THE BLOOD VESSEL OR REMOVING IT, DO NOT MOVE OR TORQUE THE GUIDEWIRE. STOP THE PROCEDURE. DETERMINE THE CAUSE OF RESISTANCE AND TAKE APPROPRIATED REMEDIAL ACTION."

    Additional Manufacturer Narrative · 1

    (B)(4). DESCRIPTION OF LOT HISTORY REVIEW IS CORRECTED TO READ AS: LOT HISTORY REVIEW REVEALED NO ANOMALY RELATING TO THE REPORTED EVENT IN THE PRODUCTION AND INSPECTION RECORD. NO OTHER SIMILAR PRODUCT EXPERIENCE REPORT WAS RECEIVED FOR THIS LOT. (B)(4) PRODUCTS ARE INSPECTED AS PART OF THE PRODUCTION PROCESS, AND MUST MEET THEIR PRODUCT SPECIFICATION CRITERIA PRIOR TO FINAL RELEASE. THERE WERE NO ANOMALIES FOUND IN THE FINAL RELEASE RECORDS FOR THE LOT INVOLVED IN THIS REPORTED EVENT AND NO INDICATION OF PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    REPORTEDLY, THE PATIENT HAD AN EMERGENCY PCI FOR AMI AT LAD#7 SEVEN DAYS BEFORE. AND ON THIS DAY, HE HAD ADDITIONAL PCI FOR 90-99% STENOSED LESION WITH REMAINING CALCIFICATION AT LAD#9 (D1). AFTER FAILURE IN CROSSING LESION WITH OTHER SEVERAL GUIDEWIRES, SUBJECT GUIDEWIRE WAS USED, HOWEVER AGAIN THE CROSSING WAS UNSUCCESSFUL, AND SOME DAMAGE WAS OBSERVED WITH IT COIL. PHYSICIAN USED A ROTATIONAL ATHERECTOMY DEVICE TO CUT THE GUIDEWIRE TO BAIL OUT, AND DEPLOYED A STENT TO FIX THE SEPARATED DISTAL FRAGMENT AGAINST VESSEL WALL. PATIENT STAYED IN HOSPITAL FOR RECOVERY ADDITIONAL PERIOD AND DISCHARGED 14 DAYS AFTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231712 ASAHI CONFIANZA PRO 8-20 PTCA GUIDEWIRE DQX ASAHI INTECC CO., LTD. NA 150724A41A

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R