BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHARGER?

    MDR report key: 4052017 · Received September 2, 2014

    Report

    Report Number
    2134265-2014-05189
    Event Type
    Malfunction
    Date Received
    September 2, 2014
    Date of Event
    August 6, 2014
    Report Date
    August 6, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K112697
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: A VISUAL AND MICROSCOPIC EXAMINATION OF THE BALLOON MATERIAL IDENTIFIED A LONGITUDINAL TEAR IN THE BALLOON. THE TEAR EXTENDED FROM 2MM DISTAL TO THE DISTAL EDGE OF THE PROXIMAL MARKERBAND AND THE TEAR EXTENDED DISTALLY ALONG THE BALLOON FOR 50MM IN LENGTH. A MICROSCOPIC EXAMINATION OF THE BALLOON MATERIAL AND MARKERBANDS COULD NOT IDENTIFY ANY ISSUES WHICH COULD POTENTIALLY HAVE CONTRIBUTED TO THE TEAR. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE HAS BEEN DETERMINED TO BE USE/USER ERROR AS THE COMPLAINT STATES THAT THE BALLOON WAS INFLATED ABOVE ITS RATED BURST PRESSURE. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED SUBCLAVIAN VEIN. A 10.0 X40, 75CM CHARGER¿ BALLOON CATHETER WAS ADVANCED. THE BALLOON WAS INFLATED AT 24 ATMOSPHERES (ATMS) FOR 1 MINUTE ON THE FIRST AND SECOND INFLATION. THE BALLOON RUPTURED AT 24 ATMS FOR 1 MINUTE ON THE THIRD INFLATION. THE DEVICE WAS REMOVED COMPLETELY FROM THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENTS STATUS WAS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED SUBCLAVIAN VEIN. A 10.0 X40, 75CM CHARGER¿ BALLOON CATHETER WAS ADVANCED. THE BALLOON WAS INFLATED AT 24 ATMOSPHERES (ATMS) FOR 1 MINUTE ON THE FIRST AND SECOND INFLATION. THE BALLOON RUPTURED AT 24 ATMS FOR 1 MINUTE ON THE THIRD INFLATION. THE DEVICE WAS REMOVED COMPLETELY FROM THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENTS STATUS WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532754 CHARGER? CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY H74939206100470 17096052

    Patients

    Seq Age Sex Outcome Treatment
    1