BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WANDA?

    MDR report key: 4111055 · Received September 23, 2014

    Report

    Report Number
    2134265-2014-05717
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Report Date
    August 27, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR. DEVICE EVALUATED BY MANUFACTURER: A VISUAL AND TACTILE EXAMINATION FOUND NO KINKS OR DAMAGE ALONG THE SHAFT OF THE DEVICE. NO ISSUES WERE NOTED WITH THE TIP SECTION OF THE DEVICE. THE DEVICE WAS ATTACHED TO AN ENCORE INFLATION UNIT, SUBJECTED TO POSITIVE PRESSURE AND A BALLOON PINHOLE WAS IDENTIFIED 15MM DISTAL TO THE PROXIMAL EDGE OF THE PROXIMAL MARKERBAND. 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

    PATIENT AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR# 2134265-2014-05718. IT WAS REPORTED THAT DURING A BALLOON ANGIOPLASTY, MULTIPLE BALLOON RUPTURES OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). WHILE TRYING TO DILATE THE SFA THE PHYSICIAN USED TWO WANDA BALLOON CATHETERS (WANDA 4.0-40, 135 AND A WANDA 5.0-80, 80) AND BOTH BURST. THE PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE WITH A 5.0 X 80MM MUSTANG BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BALLOON ANGIOPLASTY, MULTIPLE BALLOON RUPTURES OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). WHILE TRYING TO DILATE THE SFA THE PHYSICIAN USED TWO WANDA BALLOON CATHETERS (WANDA 4.0-40, 135 AND A WANDA 5.0-80, 80) AND BOTH BURST. THE PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE WITH A 5.0 X 80MM MUSTANG BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591548 WANDA? CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY H965SCH505280 17006325

    Patients

    Seq Age Sex Outcome Treatment
    1