BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUSTANG?

    MDR report key: 3073500 · Received April 23, 2013

    Report

    Report Number
    2134265-2013-02488
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 26, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K103751
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE CATHETER WAS RECEIVED WITH A GUIDEWIRE INSERTED / TRAPPED INSIDE THE WIRE LUMEN. AN EXAMINATION OF THE CATHETER FOUND NO VISIBLE DAMAGE HOWEVER THE GUIDEWIRE APPEARED TO BE KINKED INSIDE THE CATHETER SHAFT AT 34CM PROXIMAL TO THE TIP. A KINK WAS ALSO PRESENT IN A SECTION OF THE GUIDEWIRE WHICH WAS EXITING OUT FROM THE GUIDEWIRE HUB SECTION OF THE CATHETER. ATTEMPTS TO REMOVE THE GUIDEWIRE FAILED. AS A RESULT THE DEVICE AND GUIDEWIRE WERE IMMERSED IN WARM WATER FOR 24 HOURS AND WHEN AN ATTEMPT WAS MADE TO WITHDRAW THE GUIDEWIRE IT PASSED OUT THROUGH THE TIP OF THE CATHETER. IT WAS NOTED THAT RESISTANCE WAS ENCOUNTERED DURING THE WITHDRAWAL OF THE WIRE HOWEVER, WHEN THE KINKED SECTION OF THE GUIDEWIRE WAS WITHDRAWN, NO MORE RESISTANCE WAS FELT WITH THE MOVEMENT OF THE WIRE THROUGH THE CATHETER. 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 AND/OR PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERIPHERAL ANGIOPLASTY TREATMENT PROCEDURE, THE CATHETER BECAME STUCK ON THE GUIDEWIRE. THE TARGET LESION WAS LOCATED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY. THE PHYSICIAN WAS ATTEMPTING TO ADVANCE A 5X40MMX135CM MUSTANG BALLOON OVER A .035 / 260CM NON-BSC GUIDEWIRE WHEN THE "ENTIRE" CATHETER GOT STUCK ON THE GUIDEWIRE. "PHYSICIAN QUESTIONED IF THE GUIDEWIRE WAS ACTUALLY A .035." THE CATHETER AND GUIDEWIRE WERE REMOVED AS ONE UNIT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT NON-BSC GUIDEWIRE AND A 6X60MMX135CM MUSTANG BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERIPHERAL ANGIOPLASTY TREATMENT PROCEDURE, THE CATHETER BECAME STUCK ON THE GUIDEWIRE. THE TARGET LESION WAS LOCATED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY. THE PHYSICIAN WAS ATTEMPTING TO ADVANCE A 5X40MMX135CM MUSTANG BALLOON OVER A .035 / 260CM NON-BSC GUIDEWIRE WHEN THE "ENTIRE" CATHETER GOT STUCK ON THE GUIDEWIRE. "PHYSICIAN QUESTIONED IF THE GUIDEWIRE WAS ACTUALLY A .035." THE CATHETER AND GUIDEWIRE WERE REMOVED AS ONE UNIT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT NON-BSC GUIDEWIRE AND A 6X60MMX135CM MUSTANG BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173950 MUSTANG? CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY H74939171050410 0015801268

    Patients

    Seq Age Sex Outcome Treatment
    1 .035 - 260CM COOK AMPLATZ GUIDE WIRE