BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEPATH¿

    MDR report key: 2882610 · Received December 20, 2012

    Report

    Report Number
    2134265-2012-08455
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    December 4, 2012
    Report Date
    December 4, 2012
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    DQX
    PMA / PMN Number
    K101599
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: EXAMINATION OF THE RETURNED PRODUCT REVEALED THE WIRE WAS RETURNED STUCK INSIDE A NON BSC .038 CATHETER AND WAS UNABLE TO BE REMOVED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, GUIDE WIRE ENTRAPMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A .038 5FR NON BSC GUIDE CATHETER WAS POSITIONED IN THE PATIENT. THE TRUEPATH CTO DEVICE WAS THEN ADVANCED THROUGH THE PROXIMAL CAP OF THE LESION. WHILE ATTEMPTING TO REMOVE THE TRUEPATH, IT WAS NOTED THAT IT HAD BECOME STUCK IN THE CATHETER. THE DEVICES WERE REMOVED TOGETHER AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, GUIDE WIRE ENTRAPMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A .038 5FR NON BSC GUIDE CATHETER WAS POSITIONED IN THE PATIENT. THE TRUEPATH CTO DEVICE WAS THEN ADVANCED THROUGH THE PROXIMAL CAP OF THE LESION. WHILE ATTEMPTING TO REMOVE THE TRUEPATH, IT WAS NOTED THAT IT HAD BECOME STUCK IN THE CATHETER. THE DEVICES WERE REMOVED TOGETHER AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUEPATH¿ WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - CORK H74939208181650 0012060801

    Patients

    Seq Age Sex Outcome Treatment
    1 TERUMO ANGLED TAPER .038 GLIDECATH 5FR