BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUSTANG?

    MDR report key: 4093894 · Received September 16, 2014

    Report

    Report Number
    2134265-2014-05680
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 29, 2014
    Report Date
    August 29, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K110122
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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.: AN EXAMINATION OF THE BALLOON IDENTIFIED NO TEARS OR HOLES IN THE BALLOON MATERIAL. THE DEVICE WAS ATTACHED TO AN ENCORE INFLATION UNIT AND THE BALLOON WAS INFLATED TO ITS RATED BURST PRESSURE WITH NO LEAKS NOTED. A VACUUM WAS PULLED AND THE BALLOON DEFLATED FULLY. THE BALLOON WAS INFLATED AND DEFLATED ON THREE MORE OCCASIONS WITH NO ANOMALIES NOTED. 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 BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED AND MODERATELY TORTUOUS COMMON ILIAC ARTERY. POST DEPLOYMENT OF A 10X40MM NON-BSC STENT, A 9.0 X 20, 75CM MUSTANG¿ BALLOON CATHETER WAS ADVANCED FOR POST DILATATION. THERE WAS NO KINK OR RESISTANCE ENCOUNTERED DURING THE PROCEDURE. UPON ADVANCING, THE DEVICE SEEMED TO CAME INTO CONTACT WITH THE EDGE OF THE NON-BSC STENT AND WHEN PHYSICIAN WAS TO INFLATE THE BALLOON, IT WAS NOTED THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH PLACEMENT OF A 9X40MM NON-BSC STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED AND MODERATELY TORTUOUS COMMON ILIAC ARTERY. POST DEPLOYMENT OF A 10X40MM NON-BSC STENT, A 9.0 X 20, 75CM MUSTANG¿ BALLOON CATHETER WAS ADVANCED FOR POST DILATATION. THERE WAS NO KINK OR RESISTANCE ENCOUNTERED DURING THE PROCEDURE. UPON ADVANCING, THE DEVICE SEEMED TO CAME INTO CONTACT WITH THE EDGE OF THE NON-BSC STENT AND WHEN PHYSICIAN WAS TO INFLATE THE BALLOON, IT WAS NOTED THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH PLACEMENT OF A 9X40MM NON-BSC STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571304 MUSTANG? CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY H74939171090270 16827264

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: RADIFOCUS (TERUMO)| INTRODUCER SHEATH: OPTIMO (TOKAI MEDICAL)