BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUSTANG?

    MDR report key: 3922906 · Received July 9, 2014

    Report

    Report Number
    2134265-2014-03902
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K110122
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR., EVAL SUMMARY ATTACHED, METHOD CODES, RESULT CODES, CONCLUSION CODES UPDATED. DEVICE EVALUATED BY MFR.; A VISUAL EXAMINATION OF THE RETURNED DEVICE IDENTIFIED THAT THE SHAFT OF THE BALLOON CATHETER WAS SEVERELY STRETCHED AND BUNCHED AT VARIOUS LOCATIONS ALONG ITS LENGTH. AS A RESULT OF THIS STRETCHING THE SHAFT WAS STRETCHED DOWN ONTO THE GUIDEWIRE THAT WAS INSERTED THROUGH THE CATHETER. THE GUIDEWIRE WAS TRAPPED. THIS SIZE GUIDEWIRE IS SMALLER THAN THE RECOMMENDED SIZE GUIDEWIRE FOR USE WHICH IS 0.035INCH. A Y-GATE ADAPTER WAS FREE MOVING ALONG THE SHAFT. AN EXAMINATION OF THE BALLOON FOUND THAT THE BALLOON HAD BEEN INFLATED AND WAS NOT REFOLDED. NO TEARS WERE VISIBLE IN THE BALLOON. DUE TO THE CONDITION OF THE STRETCHED DEVICE IT WAS NOT POSSIBLE TO INFLATE THE BALLOON. 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).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CATHETER DIFFICULTY REMOVAL OCCURRED. THE 70-80 % STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND MODERATELY TORTUOUS EXTERNAL ILIAC ARTERY. A 5 FRENCH 90CM NON BSC SHEATH WAS PLACED THEN AN 8X80MM NON BSC STENT WAS PLACED. FOLLOWING STENT PLACEMENT THE 7.0X40X135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR POST DILATION. THE BALLOON WAS SUCCESSFULLY INFLATED THREE TIMES. UPON REMOVAL, THE PHYSICIAN NOTED SIGNIFICANT RESISTANCE ONCE THE BALLOON WAS IN THE SHEATH. THE PHYSICIAN PULLED THE BALLOON OUT SLOWLY AND THE BALLOON CATHETER WAS STRETCHING. EVENTUALLY THE PHYSICIAN HAD TO PULL THE ENTIRE SYSTEM WITH SHEATH OUT IN ORDER TO COMPLETE THE CASE. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CATHETER DIFFICULTY REMOVAL OCCURRED. THE 70-80 % STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND MODERATELY TORTUOUS EXTERNAL ILIAC ARTERY. A 5 FRENCH 90CM NON BSC SHEATH WAS PLACED THEN AN 8X80MM NON BSC STENT WAS PLACED. FOLLOWING STENT PLACEMENT THE 7.0X40X135CM MUSTANG (TM) BALLOON CATHETER WAS ADVANCED FOR POST DILATION. THE BALLOON WAS SUCCESSFULLY INFLATED THREE TIMES. UPON REMOVAL, THE PHYSICIAN NOTED SIGNIFICANT RESISTANCE ONCE THE BALLOON WAS IN THE SHEATH. THE PHYSICIAN PULLED THE BALLOON OUT SLOWLY AND THE BALLOON CATHETER WAS STRETCHING. EVENTUALLY THE PHYSICIAN HAD TO PULL THE ENTIRE SYSTEM WITH SHEATH OUT IN ORDER TO COMPLETE THE CASE. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399447 MUSTANG? CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY H74939171070410 0016676672

    Patients

    Seq Age Sex Outcome Treatment
    1 5 FRENCH 90CM COOK SHUTTLE SHEATH| COOK ZILVER 518 8X80 STENT