BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XXL? VASCULAR

    MDR report key: 4051866 · Received September 2, 2014

    Report

    Report Number
    2134265-2014-05166
    Event Type
    Malfunction
    Date Received
    September 2, 2014
    Date of Event
    May 22, 2014
    Report Date
    August 7, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    KNQ
    PMA / PMN Number
    K952656
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: THE DEVICE WAS RECEIVED IN TWO HALVES. A BREAK WAS IDENTIFIED WITHIN THE INFLATION LUMEN 33MM DISTAL TO THE PROXIMAL END OF THE PROXIMAL BALLOON SLEEVE. A COMPLETE BALLOON CIRCUMFERENTIAL TEAR WAS EVIDENT 40MM DISTAL TO THE PROXIMAL END OF THE PROXIMAL BALLOON SLEEVE. SOLIDIFIED BLOOD WAS CLEARLY VISIBLE WITHIN THE INFLATION LUMEN. THE BALLOON MATERIAL WAS WRAPPED AROUND THE DISTAL TIP OF THE DEVICE SHIELDING IT FROM VIEW. THE DISTAL SECTION OF THE BREAK WAS PLACED IN A SOLUTION OF (B)(4) MUCOSOL DISINFECTANT AND (B)(4) WATER WITHIN SEALED A BEAKER AND IMMERSED IN A HEATED WATERBATH AT (B)(4) FOR TWO DAYS. THE BALLOON MATERIAL WAS THEN UNRAVELED TO EXPOSE THE TIP OF THE DEVICE. NO ISSUES WERE NOTED WITH THE PROFILE OF THE TIP OR THE DISTAL BOND. THE SHAFT BREAK APPEARED TO BE DUCTILE IN NATURE AS THERE WAS EVIDENCE OF MATERIAL RESISTANCE AT THE POINT OF THE BREAK. THE DISTAL SECTION OF THE BREAK WAS OBSERVED TO BE KINKED AT VARIOUS POINTS ALONG ITS LENGTH. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. 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

    COMPLAINT WAS ORIGINALLY ASSESSED REPORTABLE FOR (B)(4), HOWEVER THIS IS NOW REPORTABLE BASED ON ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2014. IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUBCLAVIAN ARTERY. THE 14-4/5.8/75 XXL¿ VASCULAR BALLOON CATHETER WAS ADVANCED TO DILATE THE LESION. THE BALLOON WAS INFLATED HOWEVER, IT RUPTURED UNDER RATED BURST. THE PHYSICIAN WAS ABLE TO REMOVE EVERYTHING OUT FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS FINE. HOWEVER, ADDITIONAL INFORMATION REVEALED A SHAFT BREAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532802 XXL? VASCULAR DILATOR, ESOPHAGEAL KNQ BOSTON SCIENTIFIC - GALWAY M001145140 16595184

    Patients

    Seq Age Sex Outcome Treatment
    1