BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI PROWATER PTCA GUIDE WIRE

    MDR report key: 2511859 · Received March 30, 2012

    Report

    Report Number
    3003775027-2012-00013
    Event Type
    Injury
    Date Received
    March 30, 2012
    Date of Event
    March 5, 2012
    Report Date
    March 6, 2012
    Manufacturer
    AV-ASAHI
    Product Code
    DQX
    PMA / PMN Number
    K022762
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS MANUFACTURED BY ASAHI INTECC. CO. LTD. MEDICAL DIVISION; HOWEVER, ABBOTT VASCULAR DISTRIBUTES THE DEVICE AND IS RESPONSIBLE FOR MDR REPORTING. THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE ANALYSIS WAS PERFORMED BY (B)(4): RETURNED PROWATER GUIDE WIRE WAS FOUND ITS CORE WIRE SEPARATED AT 20 MILLIMETERS FROM TIP END (NOT AT 15 CENTIMETERS), NO NOTABLE COIL STRETCH WAS OBSERVED WITH THE SEPARATED DISTAL SECTION, WHILE AT THE PROXIMAL SECTION THE COIL WAS STRAIGHTENED TOWARD DISTAL END FOR SOME-PITCH-LENGTH AT THE DISTAL SIDE OF MIDDLE BRAZING. SCANNING ELECTRON MICROSCOPY (SEM) OBSERVATION REVEALED THE DIMPLES ON THE CORE WIRE BREAKAGE SURFACE, AND THE REDUCTION OF THE CORE WIRE DIAMETER AT THE SECTION JUST ADJACENT TO THE BREAKAGE SITE. BOTH WERE SUGGESTING GUIDE WIRE BREAKAGE DUE TO PULL APART FORCE. WITH THE INVESTIGATION OF RETURNED GUIDE WIRE, IT IS CONCLUDED THAT THE GUIDE WIRE MIGHT BE TRAPPED BY LESION, OR SOME OTHER CAUSE, WHERE PULL BACK MANIPULATION WAS APPLIED WITH A FORCE, SO THAT THE GUIDE WIRE WAS BROKEN AND SEPARATED DUE TO THE FORCE EXCEEDING THE PRODUCT DESIGN LIMIT. LOT HISTORY REVIEW REVEALED NO ANOMALY RELATING TO THE REPORTED EVENT. NO OTHER PRODUCT EXPERIENCE REPORT WAS RECEIVED FOR THIS LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN THE NON TORTUOUS CIRCUMFLEX CORONARY ARTERY, IN A NON-CALCIFIED LESION, AN ASAHI PROWATER GUIDE WIRE SEPARATED, APPROXIMATELY 15 CENTIMETERS FROM THE DISTAL END, INSIDE OF THE PATIENT ANATOMY. A NON-COMPLIANT SNARE WAS USED TO RETRIEVE THE WIRE PIECE. THERE WAS NO RESISTANCE DURING ADVANCEMENT OR DURING REMOVAL OF THE GUIDE WIRE. THERE WAS NO PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASAHI PROWATER PTCA GUIDE WIRE GUIDE WIRE DQX AV-ASAHI 100909A211

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention