BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XXL? VASCULAR

    MDR report key: 4131344 · Received October 1, 2014

    Report

    Report Number
    2134265-2014-05823
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 2, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    KNQ
    PMA / PMN Number
    K952656
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS. SIGNIFICANT AMOUNTS OF BLOOD WERE VISIBLE IN THE INFLATION LUMEN WHICH IS INDICATIVE OF A BALLOON BURST. A VISUAL EXAMINATION OF THE RETURNED DEVICE IDENTIFIED A LONGITUDINAL TEAR WITH A SMALL CIRCUMFERENTIAL TEAR IN THE BALLOON MATERIAL. THE TEAR WAS IDENTIFIED 21MM PROXIMAL TO THE TIP OF THE DEVICE. THE TEAR WAS NOT A COMPLETE CIRCUMFERENTIAL TEAR AND EXTENDED APPROXIMATELY 11MM OVER THE BALLOON MATERIAL. AS A RESULT NONE OF THE BALLOON HAD DETACHED. A VISUAL AND TACTILE EXAMINATION FOUND THAT THE SHAFT WAS KINKED AT VARIOUS POSITIONS ALONG ITS LENGTH. 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 REMOVAL DIFFICULTIES AND BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC VEIN. AFTER A WALLSTENT WAS DEPLOYED TO THE LESION, THE XXL/14-4/5.8/75 XXL¿ VASCULAR BALLOON CATHETER WAS ADVANCED FOR POST DILATATION. HOWEVER, DURING UNSPECIFIED INFLATION AT 6 ATMOSPHERES, THE BALLOON RUPTURED AND GOT HUNG UP ON THE STENT. THE PHYSICIAN THEN FURTHER ADVANCED THE DEFLATED BALLOON, TURNED IT AND WAS ABLE TO COMPLETELY REMOVE THE DEVICE FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REMOVAL DIFFICULTIES AND BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC VEIN. AFTER A WALLSTENT WAS DEPLOYED TO THE LESION, THE XXL/14-4/5.8/75 XXL¿ VASCULAR BALLOON CATHETER WAS ADVANCED FOR POST DILATATION. HOWEVER, DURING UNSPECIFIED INFLATION AT 6 ATMOSPHERES, THE BALLOON RUPTURED AND GOT HUNG UP ON THE STENT. THE PHYSICIAN THEN FURTHER ADVANCED THE DEFLATED BALLOON, TURNED IT AND WAS ABLE TO COMPLETELY REMOVE THE DEVICE FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610585 XXL? VASCULAR DILATOR, ESOPHAGEAL KNQ BOSTON SCIENTIFIC - GALWAY M001145140 17114678

    Patients

    Seq Age Sex Outcome Treatment
    1