BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WANDA¿

    MDR report key: 2221052 · Received August 23, 2011

    Report

    Report Number
    2134265-2011-03871
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    July 25, 2011
    Report Date
    July 25, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: VISUAL AND TACTILE EXAMINATION OF THE RETURNED DEVICE REVEALED NO DAMAGE NOTED TO THE SHAFT OF THE DEVICE. THE BALLOON WAS NOT FOLDED OR WRAPPED AROUND THE SHAFT. THE DEVICE WAS ATTACHED TO AN ENCORE INFLATION UNIT IN AN ATTEMPT TO INFLATE THE BALLOON TO ITS RATE BURST PRESSURE WHEN A LEAK WAS NOTED IN THE SHAFT 14MM PROXIMAL TO THE PROXIMAL EDGE OF THE PROXIMAL MARKERBAND. MICROSCOPIC EXAMINATION OF THE LEAK SITE NOTED A TEAR OF LESS THAN 1MM IN THE SHAFT WALL OF THE DEVICE. THIS DAMAGE MAY BE CONSISTENT WITH THE DEVICE COMING IN CONTACT WITH A SHARP OBJECT. 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE A HOLE IN THE SHAFT WAS NOTED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 5.0-40, 80 WANDA BALLOON CATHETER WAS ADVANCED TO THE TARGET LESION. DURING THE FIRST INFLATION BETWEEN APPROXIMATELY 2-3 ATMS CONTRAST APPEARED TO BE LEAKING OUT OF THE SHAFT APPROXIMATELY 1-2 CM "BEFORE THE ORIGIN OF THE BALLOON." THE BALLOON WAS DEFLATED AND THE DEVICE WAS REMOVED FROM THE PATIENT. SALINE WAS INJECTED INTO THE PORT OF THE BALLOON AND THERE APPEARED TO BE A SMALL HOLE IN THE SHAFT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE A HOLE IN THE SHAFT WAS NOTED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 5.0-40, 80 WANDA BALLOON CATHETER WAS ADVANCED TO THE TARGET LESION. DURING THE FIRST INFLATION BETWEEN APPROXIMATELY 2-3 ATMS CONTRAST APPEARED TO BE LEAKING OUT OF THE SHAFT APPROXIMATELY 1-2 CM "BEFORE THE ORIGIN OF THE BALLOON." THE BALLOON WAS DEFLATED AND THE DEVICE WAS REMOVED FROM THE PATIENT. SALINE WAS INJECTED INTO THE PORT OF THE BALLOON AND THERE APPEARED TO BE A SMALL HOLE IN THE SHAFT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WANDA¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY H965SCH505070 14292109

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE, .035 HYDROPHILIC| INTRODUCER SHEATH, 6F CORDIS BRITE TIP