BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI CONFIANZA PRO PTCA GUIDE WIRE

    MDR report key: 3640106 · Received February 21, 2014

    Report

    Report Number
    3003775027-2014-00015
    Event Type
    Injury
    Date Received
    February 21, 2014
    Date of Event
    January 24, 2014
    Report Date
    January 28, 2014
    Manufacturer
    AV-ASAHI
    Product Code
    DQX
    PMA / PMN Number
    K041531
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS MANUFACTURED BY ASAHI INTECC. CO. LTD. MEDICAL DIVISION; HOWEVER, ABBOTT VASCULAR DISTRIBUTES THE DEVICE AND IS RESPONSIBLE FOR MDR REPORTING. EVALUATION SUMMARY: THE ANALYSIS WAS PERFORMED BY ASAHI INTECC. CO. LTD: THE GUIDE WIRE WAS RETURNED AND THE REPORTED SEPARATION WAS CONFIRMED. SCANNING ELECTRON MICROSCOPE (SEM) REVEALED THAT BOTH THE CORE WIRE AND THE COIL WIRE WERE BROKEN AFTER LOCALLY TWISTED AND KINKED. THOUGH THE DETAILED INFORMATION ON PROCESS AND OF USE OF GUIDE WIRE WAS NOT PROVIDED, WITH THE OUTCOMES OF THE INVESTIGATION OF RETURNED GUIDE WIRE IT IS INFERRED THAT THE GUIDE WIRE TIP END MIGHT BE TRAPPED BY THE TARGET LESION OR IN THE VESSEL, WHERE ROTATIONAL MANIPULATION WAS MADE TO THE GUIDE WIRE AND THE DISTAL END OF THE GUIDE WIRE MIGHT BE LOOPED AND KINKED. THE CORE WIRE WAS BROKEN DUE TO ROTATIONAL FORCE THAT EXCEEDED THE PRODUCT DESIGN LIMIT. A LOT HISTORY REVIEW REVEALED NO ANOMALY RELATING TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A TOTALLY OCCLUDED LESION IN THE ANTERIOR TIBIAL ARTERY. THE CONFIANZA PRO GUIDE WIRE WAS USED WITHOUT ISSUE. AFTER REMOVAL, IT WAS NOTED THAT THE TIP WAS SEPARATED, AND REMAINED IN THE PATIENT ANATOMY. AN ATTEMPT WAS MADE TO SNARE THE SEPARATED PORTION, BUT WAS UNSUCCESSFUL. THE PLANNED STENTS WERE IMPLANTED TO SECURE THE SEPARATED PORTION AGAINST THE VESSEL WALL. THE PATIENT HAD A GOOD OUTCOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109624 ASAHI CONFIANZA PRO PTCA GUIDE WIRE GUIDE WIRE DQX AV-ASAHI 121005A44S

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention GUIDE CATH: QUICK CROSS