BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PT²¿

    MDR report key: 2980864 · Received February 27, 2013

    Report

    Report Number
    2134265-2013-01096
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    January 24, 2013
    Report Date
    February 1, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    DQX
    PMA / PMN Number
    K030617
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER - THE DEVICE RETURNED IN TWO SECTIONS THE PROXIMAL SECTION PRESENTED A KINK AT 146.1 CM FROM THE PROXIMAL END. THE DISTAL SECTION PRESENTED A KINK AT 36.6 CM FROM THE PROXIMAL END. ALL DIMENSIONAL MEASUREMENT WERE WITHIN SPECIFICATIONS. EXTERNAL ANALYSIS REVEALED OF EVIDENCE OF A MECHANICAL CUT WITH TENSION OVERLOAD TYPICAL IN THE INDUSTRIAL PROCESS AS MODE OF WIRE FAILURE AND EVIDENCE OF BENDING OVERLOAD EVENT AS MODE WIRE FAILURE. EACH SECTION PRESENTED DIFFERENT FAILURE CHARACTERISTICS AND DIMENSIONS, SUGGESTING THAT THESE TWO ARE NOT FROM THE SAME FRACTURE. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ANGIOPLASTY PROCEDURE, A WIRE BREAK OCCURRED. VASCULAR ASSESS WAS GAINED VIA THE RADIAL ARTERY. AS THE 185 CM MODERATE SUPPORT PT2 GUIDEWIRE WAS ADVANCED THROUGH THE RADIAL ARTERY A SWITCHBACK BEND WAS FORMED WITH APPROXIMATELY 40 CM OF WIRE OUTSIDE THE ACCESS CATHETER TIP. THE BEND OCCURRED IN THE DISTAL TRANSITION OF THE WIRE TIP. THE PHYSICIAN CHOOSE TO REMOVE THE CATHETER AND WIRE AS A UNIT DUE TO THE POTENTIAL RISK OF BREAKAGE. UPON REMOVAL FROM THE PATIENT THE GUIDEWIRE BROKE INTO TWO PIECES. THE PROCEDURE WAS COMPLETED WITH ANOTHER PT2 WIRE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ANGIOPLASTY PROCEDURE, A WIRE BREAK OCCURRED. VASCULAR ASSESS WAS GAINED VIA THE RADIAL ARTERY. AS THE 185 CM MODERATE SUPPORT PT2 GUIDEWIRE WAS ADVANCED THROUGH THE RADIAL ARTERY A SWITCHBACK BEND WAS FORMED WITH APPROXIMATELY 40 CM OF WIRE OUTSIDE THE ACCESS CATHETER TIP. THE BEND OCCURRED IN THE DISTAL TRANSITION OF THE WIRE TIP. THE PHYSICIAN CHOOSE TO REMOVE THE CATHETER AND WIRE AS A UNIT DUE TO THE POTENTIAL RISK OF BREAKAGE. UPON REMOVAL FROM THE PATIENT THE GUIDEWIRE BROKE INTO TWO PIECES. THE PROCEDURE WAS COMPLETED WITH ANOTHER PT2 WIRE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85693 PT²¿ WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA (COYOL) H74938931030

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR