BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS? LD VASCULAR

    MDR report key: 3053114 · Received April 11, 2013

    Report

    Report Number
    2134265-2013-02162
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 14, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: THE DEVICE WAS RECEIVED FOR ANALYSIS. A VISUAL EXAMINATION OF THE DEVICE NOTED NO DAMAGE TO THE SHAFT OF THE DEVICE. THE BALLOON SHOWED EVIDENCE OF BEING INFLATED. THERE WAS NO DAMAGE NOTED TO THE DISTAL TIP OF THE DEVICE. THE DEVICE WAS ATTACHED TO AN ENCORE INFLATION UNIT AND A POSITIVE PRESSURE WAS APPLIED WHEN A LEAK WAS NOTED. A MICROSCOPIC EXAMINATION OF THE BALLOON MATERIAL NOTED A PINHOLE LOCATED OVER THE PROXIMAL EDGE OF THE PROXIMAL MARKERBAND. NO OTHER ISSUES WERE NOTED WITH THE DEVICE. 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 OR OLDER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERIPHERAL STENTING TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. USING A FEMORAL APPROACH, THE 90% STENOSED LESION WAS LOCATED IN A NON-CALCIFIED, MODERATELY TORTUOUS SUB CLAVIAN ARTERY. THE 8.0 X 40 X 135 CM EXPRESS-VASCULAR LD STENT DELIVERY SYSTEM WAS ADVANCED TO THE LESION WHEN THE STENT DELIVERY BALLOON RUPTURED AT UNKNOWNS ATMS UPON FIRST INFLATION. THE RUPTURED BALLOON WAS REMOVED INTACT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERIPHERAL STENTING TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. USING A FEMORAL APPROACH, THE 90% STENOSED LESION WAS LOCATED IN A NON-CALCIFIED, MODERATELY TORTUOUS SUB CLAVIAN ARTERY. THE 8.0 X 40 X 135 CM EXPRESS-VASCULAR LD STENT DELIVERY SYSTEM WAS ADVANCED TO THE LESION WHEN THE STENT DELIVERY BALLOON RUPTURED AT UNKNOWNS ATMS UPON FIRST INFLATION. THE RUPTURED BALLOON WAS REMOVED INTACT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156266 EXPRESS? LD VASCULAR CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY H74938162840130 0015780085

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDEWIRE: RADIFORCUS| INFLATION DEVICE: MEDTRONIC