BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI PROWATER PTCA GUIDE WIRE

    MDR report key: 1889017 · Received October 29, 2010

    Report

    Report Number
    3003775027-2010-00028
    Event Type
    Injury
    Date Received
    October 29, 2010
    Date of Event
    October 5, 2010
    Report Date
    October 5, 2010
    Manufacturer
    AV-ASAHI
    Product Code
    DQX
    PMA / PMN Number
    K022762
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE RECEIVED BY MANUFACTURER CORRECTION: DATE ON PREVIOUS SUPPLEMENTAL REPORT ENTERED INCORRECTLY AS 10/19/2010. THE DATE SHOULD HAVE BEEN 11/09/2010.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS WAS PERFORMED BY ASAHI INTECC. CO. LTD: EVALUATION OF THE RETURNED PROWATER GUIDE WIRE FOUND IT WAS SEPARATED AT THE DISTAL SIDE OF THE MIDDLE BRAZING, BOTH CORE WIRE AND COIL WIRE. THE SCANNING ELECTRON MICROSCOPY (SEM) OBSERVATION REVEALED WAVY BREAKAGE TRACE ON THE CORE WIRE BREAKAGE SURFACE, AND THE TRACE OF PULL-APART SEPARATION WITH THE COIL WIRE. IT APPEARS THAT ADVANCEMENT AND PULLBACK MANIPULATION WAS APPLIED TO THE GUIDE WIRE OF WHICH DISTAL END WAS PROLAPSED IN THE VESSEL, SO THAT MANIPULATION FORCE WAS ACCUMULATED TO THE BEND POINT AND THE GUIDE WIRE WAS FRACTURED DUE TO THE FORCE THAT EXCEEDED THE PRODUCT DESIGN LIMIT. THE COIL WIRE APPEARS TO HAVE BEEN BROKEN DUE TO PULLING FORCE WHEN THE GUIDE WIRE WAS PULLED BACK. THE DEVICE INSTRUCTION FOR USE, WARNING SECTION DESCRIBES: IF GUIDE WIRE TIP PROLAPSE IS OBSERVED, DO NOT ALLOW THE TIP TO REMAIN IN A PROLAPSED POSITION, OTHERWISE DAMAGE TO THE GUIDE WIRE MAY OCCUR, AND SEPARATION OR BREAKAGE OF GUIDEWIRE DESCRIBED AS ONE OF POSSIBLE COMPLICATIONS AND ADVERSE EVENTS. A REVIEW OF MANUFACTURING RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVAL. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADD'L RELEVANT INFO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RAMUS BRANCH. FIRST, INTRAVASCULAR ULTRA SOUND (IVUS) WAS PERFORMED AND THE ANGIOSCULP WAS DONE. THE PROWATER GUIDE WIRE TIP SEPARATED AND REMAINED IN THE PT'S RAMUS. THERE WAS NO RESISTANCE NOTED DURING USE OF THE PROWATER GUIDE WIRE. THERE WERE NO ATTEMPTS MADE TO RETRIEVE THE SEPARATED GUIDE WIRE TIP FROM THE PT. THE PROCEDURE WENT ON AND TWO STENTS WERE PLACED IN THE RAMUS, ONE STENT WAS PLACED IN THE LEFT ANTERIOR DESCENDING AND ONE STENT WAS PLACED IN THE CIRCUMFLEX. THE PT WAS DISCHARGED FROM THE HOSPITAL. THOUGH REQUESTED, NO ADD'L EVENT OR PT INFO IS AVAILABLE.

    Description of Event or Problem · 1

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASAHI PROWATER PTCA GUIDE WIRE GUIDE WIRE DQX AV-ASAHI NA 091115A401

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| O