BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUSTANG?

    MDR report key: 3172168 · Received June 17, 2013

    Report

    Report Number
    2134265-2013-04161
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 21, 2013
    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 MANUFACTURER: AN EXAMINATION OF THE BALLOON FOUND 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. THE INFLATION DEVICE WAS VERIFIED BEFORE AND AFTER USE. USING THE SAME ENCORE, A VACUUM WAS PULLED AND THE BALLOON DEFLATED WITH NO ANOMALIES NOTED. THE BALLOON WAS INFLATED AND DEFLATED FROM ITS RATED BURST PRESSURE ON THREE MORE OCCASIONS AND EACH TIME THE BALLOON INFLATED WITH NO LEAKS NOTED. HOWEVER, FURTHER EXAMINATIONS OF THE RETURNED DEVICE FOUND THAT THE TIP WAS DAMAGED. A PORTION OF THE DISTAL EDGE OF THE TIP WAS PEELED BACK PROXIMALLY. NO OTHER ISSUES EXISTED WITH THIS DEVICE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE WAS NOT CONFIRMED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE MIDDLE AREA OF THE RADIAL ARTERY WITH A 5F INTRODUCER SHEATH. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS LEFT RADIAL VEIN. A 5.0 X 40, 75CM MUSTANG¿ BALLOON CATHETER WAS APPROACHED INTO THE SHUNT AREA AND USED TO DILATE THE LESION. THE FIRST INFLATION WAS PERFORMED AT 10 ATMOSPHERES FOR 60 SECONDS AND THE 2ND INFLATION WAS PERFORMED AT 12 ATMOSPHERES FOR 60 SECONDS. UPON THE THIRD INFLATION, THE BALLOON RUPTURED AT 18 ATMOSPHERES. THE DEVICE WAS REMOVED FROM THE PATIENT SUCCESSFULLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE MIDDLE AREA OF THE RADIAL ARTERY WITH A 5F INTRODUCER SHEATH. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS LEFT RADIAL VEIN. A 5.0 X 40, 75CM MUSTANG¿ BALLOON CATHETER WAS APPROACHED INTO THE SHUNT AREA AND USED TO DILATE THE LESION. THE FIRST INFLATION WAS PERFORMED AT 10 ATMOSPHERES FOR 60 SECONDS AND THE 2ND INFLATION WAS PERFORMED AT 12 ATMOSPHERES FOR 60 SECONDS. UPON THE THIRD INFLATION, THE BALLOON RUPTURED AT 18 ATMOSPHERES. THE DEVICE WAS REMOVED FROM THE PATIENT SUCCESSFULLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273357 MUSTANG? CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY H74939171050470 15683425

    Patients

    Seq Age Sex Outcome Treatment
    1 INTRODUCER SHEATH:5F| GUIDEWIRE:035| INFLATION DEVICE:ENCORE