BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MUSTANG?

    MDR report key: 3931610 · Received July 14, 2014

    Report

    Report Number
    2134265-2014-04025
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    May 16, 2014
    Report Date
    June 16, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K110122
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: A VISUAL EXAMINATION OF THE RETURNED DEVICE IDENTIFIED THAT A BREAK OCCURRED IN THE SHAFT AND A COMPLETE BALLOON CIRCUMFERENTIAL TEAR WAS NOTED IN THE BALLOON. A COMPLETE BALLOON CIRCUMFERENTIAL TEAR WAS LOCATED AT 5.3CM DISTAL TO THE DISTAL EDGE OF THE PROXIMAL MARKERBAND. THE DISTAL SECTION OF THE BALLOON TEAR WAS NOT RETURNED FOR ANALYSIS. A VISUAL EXAMINATION OF THE DEVICE IDENTIFIED THAT A BREAK WAS NOTED IN THE SHAFT. THE SHAFT WAS SEVERELY STRETCHED AND BUCKLED AND AS A RESULT THE BREAK WAS LOCATED AT 21CM DISTAL TO THE DISTAL EDGE OF THE PROXIMAL MARKERBAND. THE DISTAL SECTION OF THE SHAFT BREAK WAS NOT RETURNED FOR ANALYSIS. THE BREAK AND SEVERE STRETCHING THAT WAS EVIDENT ARE ALL CONSISTENT WITH EXCESSIVE TENSILE FORCE HAVING BEEN APPLIED TO THE DEVICE. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS. 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 AND BALLOON DETACHMENT OCCURRED. A 8.0 X 100, 75CM MUSTANG¿ BALLOON CATHETER WAS ADVANCED TO THE TARGET LESION. THE BALLOON WAS INFLATED HOWEVER IT RUPTURED CIRCUMFERENTIALLY AT AN UNKNOWN ATMOSPHERE AND AT AN UNKNOWN NUMBER OF INFLATION. THE DISTAL PART OF THE BALLOON SEPARATED COMPLETELY AND WAS LEFT INSIDE THE PATIENT¿S BODY. THE DETACHED PORTION OF THE BALLOON WAS COMPLETELY REMOVED USING A SNARE AND IT CAME OUT ROLLED UP ON A WADDED PIECE. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS WAS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BALLOON RUPTURE AND BALLOON DETACHMENT OCCURRED. A 8.0 X 100, 75CM MUSTANG¿ BALLOON CATHETER WAS ADVANCED TO THE TARGET LESION. THE BALLOON WAS INFLATED HOWEVER IT RUPTURED CIRCUMFERENTIALLY AT AN UNKNOWN ATMOSPHERE AND AT AN UNKNOWN NUMBER OF INFLATION. THE DISTAL PART OF THE BALLOON SEPARATED COMPLETELY AND WAS LEFT INSIDE THE PATIENT¿S BODY. THE DETACHED PORTION OF THE BALLOON WAS COMPLETELY REMOVED USING A SNARE AND IT CAME OUT ROLLED UP ON A WADDED PIECE. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410233 MUSTANG? CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY H74939171081070 0016903695

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention