BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI CONFIANZA PRO PTCA GUIDE WIRE

    MDR report key: 1011248 · Received March 7, 2008

    Report

    Report Number
    3003775027-2008-00002
    Event Type
    Injury
    Date Received
    March 7, 2008
    Date of Event
    February 6, 2008
    Report Date
    February 7, 2008
    Manufacturer
    ASAHI INTECC CO., LTD. MEDICAL DIV
    Product Code
    DQX
    PMA / PMN Number
    K052339
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - PROD PERFORMANCE WAS UNABLE TO COMPLETE THEIR ANALYSIS AT THE TIME OF THIS REPORT. RESULTS AND CONCLUSIONS WILL BE FORWARDED UPON COMPLETION. EVAL SUMMARY: QA ANALYSIS OF THE DEVICE REVEALED THAT THE CORE WIRE OF THE RETURNED CONFIANZA PRO 12 WAS SEPARATED AT APPROX 6 MM DISTAL FROM THE MIDDLE BRAZING, IT SHOULD BE AT APPROX 7 MM FROM THE TIP OF THE CONFIANZA PRO 12 GUIDE WIRE. THE SEPARATED DISTAL PORTION WAS NOT RETURNED. THERE WAS A TRACE OF COUNTERCLOCKWISE (CCW) TORSION WAS FOUND AT THE ADJACENT SECTION OF THE SEPARATED SITE OF THE CORE WIRE, THEN THERE WAS A SHORT TRACE OF CLOCKWISE TORSION AT NEXT SECTION PROXIMAL TO THE CCW TORSION SECTION. THE COIL WIRE WAS STRETCHED OVER THE CORE WIRE, EXTENDED BY APPROX 20 MM TO THE DISTAL DIRECTION, AND BROKEN APART. NO OTHER ANOMALY, SUCH AS KINK OR BEND, WAS OBSERVED WITH THE COIL AND THE SHAFT. PROD PERFORMANCE ENGINEERING WAS UNABLE TO COMPLETE THEIR ANALYSIS AT THE TIME OF THIS REPORT. RESULTS AND CONCLUSIONS WILL BE FORWARDED UPON COMPLETION.

    Description of Event or Problem · 1

    REPORT STATUS: SERIOUS INJURY-PERMANENT DAMAGE. REPORT RATIONALE: GUIDE WIRE TIP REMAINS IN PT'S ANATOMY. DEVICE ISSUE: GUIDE WIRE SEPARATION. IT WAS REPORTED THAT DURING A RETROGRADE CHRONICALLY TOTALLY OCCLUDED (CTO) PROCEDURE THE TIP LOOSENED AND REMAINS IN THE OCCLUSION IN THE SUB-INTIMAL PART OF THE PROXIMAL RIGHT ARTERY. NO LUMEN WAS FOUND IN THE ARTERY. THE CTO IS APPROX TEN YRS OLD. NO ADD'L EVENT OR PT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASAHI CONFIANZA PRO PTCA GUIDE WIRE DQX ASAHI INTECC CO., LTD. MEDICAL DIV NA 7605611181

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability