BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XXL BALLOON DILATATION CATHETER

    MDR report key: 2221177 · Received August 24, 2011

    Report

    Report Number
    2134265-2011-03500
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    June 9, 2011
    Report Date
    July 28, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K952063
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: VISUAL AND TACTILE EXAMINATION OF THE RETURNED DEVICE REVEALED A KINK 12MM DISTAL TO THE STRAIN RELIEF. THE BALLOON WAS FOLDED AND WRAPPED AROUND THE SHAFT OF THE DEVICE. THERE WERE TRACES OF BLOOD PRESENT INSIDE THE BALLOON. VISUAL AND MICROSCOPIC EXAMINATION OF THE BALLOON OBSERVED A PARTIAL CIRCUMFERENTIAL TEAR IN THE BALLOON MATERIAL 15MM PROXIMAL TO THE TIP OF THE DEVICE. 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

    THIS WAS ORIGINALLY REPORTED ON THE (B)(6) REPORT. INVESTIGATION FINDINGS APPROVED ON (B)(6) 2011 SHOWS A CIRCUMFERENTIAL TEAR. IT WAS REPORTED THAT DURING A PERCUTANEOUS ANGIOPLASTY PROCEDURE A BALLOON RUPTURE OCCURRED. THE DETAILS OF THE LESION ARE UNKNOWN. THE (B)(4) BALLOON RUPTURED. NUMBER OF INFLATIONS AND TO WHAT ATMOSPHERES IS UNKNOWN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD. DEVICE ANALYSIS SHOWS A CIRCUMFERENTIAL TEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XXL BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY M001145520 14122514

    Patients

    Seq Age Sex Outcome Treatment
    1