BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WANDA?

    MDR report key: 4091490 · Received September 16, 2014

    Report

    Report Number
    2134265-2014-05598
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 26, 2014
    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)(4). DEVICE EVALUATED BY MFR: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS RECEIVED INSERTED THROUGH A 6FR INTRODUCER SHEATH. AN INITIAL EXAMINATION REVEALED THAT THE SHAFT WAS SEVERELY STRETCHED AND THE BALLOON HAD RUPTURED. IT WAS ALSO NOTED THAT THE TIP OF THE DEVICE HAD DETACHED. BLOOD AND CONTRAST MEDIA WAS ALSO VISIBLE IN THE DEVICE. A VISUAL EXAMINATION OF THE RETURNED DEVICE DETERMINED THAT THE BALLOON WAS TORN CIRCUMFERENTIALLY; HOWEVER ONLY A SMALL PORTION OF THE BALLOON MATERIAL REMAINED ATTACHED TO THE PROXIMAL END OF THE DEVICE AND THE DETACHED BALLOON MATERIAL WAS NOT RECEIVED FOR ANALYSIS. THE SHAFT WAS BROKEN APPROXIMATELY 54MM DISTAL TO THE PROXIMAL MARKERBAND. THE DISTAL PORTION OF THE BREAK WAS NOT RECEIVED FOR ANALYSIS. THE REMAINDER OF THE SHAFT WAS SEVERELY STRETCHED AND KINKED. THIS DAMAGE MAY HAVE OCCURRED DURING THE REMOVAL OF THE DEVICE FROM THE PATIENT. IT WAS NOTED THAT THE TIP OF THE DEVICE HAD DETACHED FROM THE DELIVERY SYSTEM AND WAS NOT RECEIVED FOR 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 OCCURRED. THE TARGET LESION WAS LOCATED IN THE COMMON ILIAC ARTERY. A 6.0-40, 80MM WANDA¿ BALLOON CATHETER WAS SELECTED AND WAS ADVANCED TO THE TARGET LESION. HOWEVER, A TRANSVERSE BALLOON RUPTURED OCCURRED. THE DEVICE WAS REMOVED ALONG WITH THE SHEATH AND GUIDEWIRE. IT WAS NOTED THAT ¿THE BALLOON WAS TOO SHREDDED AFTER REMOVAL TO BE CERTAIN THAT ALL OF THE BALLOON MATERIAL WAS REMOVED, BUT IT APPEARED COMPLETE¿. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE COMMON ILIAC ARTERY. A 6.0-40, 80MM WANDA¿ BALLOON CATHETER WAS SELECTED AND WAS ADVANCED TO THE TARGET LESION. HOWEVER, A TRANSVERSE BALLOON RUPTURED OCCURRED. THE DEVICE WAS REMOVED ALONG WITH THE SHEATH AND GUIDEWIRE. IT WAS NOTED THAT ¿THE BALLOON WAS TOO SHREDDED AFTER REMOVAL TO BE CERTAIN THAT ALL OF THE BALLOON MATERIAL WAS REMOVED, BUT IT APPEARED COMPLETE¿. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571632 WANDA? CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY H965SCH505100 0016787563

    Patients

    Seq Age Sex Outcome Treatment
    1