BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTOME¿ CUTTING BALLOON¿

    MDR report key: 6090899 · Received November 9, 2016

    Report

    Report Number
    2134265-2016-09897
    Event Type
    Injury
    Date Received
    November 9, 2016
    Date of Event
    October 14, 2016
    Report Date
    October 17, 2016
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NWX
    PMA / PMN Number
    P950020
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE DEVICE WAS RETURNED FOR ANALYSIS. DEVICE ANALYSIS REVEALED THAT THE HYPOTUBE WAS KINKED IN MULTIPLE LOCATIONS. THESE KINKS WERE CONSISTENT WITH EXCESSIVE FORCE HAVING BEEN APPLIED TO THE DELIVERY SYSTEM. AN EXAMINATION OF THE SHAFT POLYMER EXTRUSION WAS PERFORMED AND IDENTIFIED NO KINKS AND DAMAGE. NO DAMAGE WAS OBSERVED TO THE BALLOON; HOWEVER THE BALLOON FOLDS WERE NOTED TO BE RELAXED. AN EXAMINATION OF THE BLADES FOUND THAT THE BLADES WERE DISCOLOURED. NO PHYSICAL DAMAGE WAS FOUND WITH ANY OF THE BLADES. 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).

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WITHDRAWAL DIFFICULTIES OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). A 10/3.25 FLEXTOME¿ CUTTING BALLOON¿ WAS SELECTED FOR USE. AFTER THE PHYSICIAN PERFORMED BALLOON DILATATION 3-4 TIMES, THE BALLOON WAS UNABLE TO BE WITHDRAWN. A NON BSC GUIDE CATHETER WAS USED FOR RETRIEVAL AND ANOTHER BALLOON WAS INFLATED TO REMOVE THE DEVICE. THE PROCEDURE WAS COMPLETED WITH A NON BSC DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WITHDRAWAL DIFFICULTIES OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). A 10/3.25 FLEXTOME¿ CUTTING BALLOON¿ WAS SELECTED FOR USE. AFTER THE PHYSICIAN PERFORMED BALLOON DILATATION 3-4 TIMES, THE BALLOON WAS UNABLE TO BE WITHDRAWN. A NON BSC GUIDE CATHETER WAS USED FOR RETRIEVAL AND ANOTHER BALLOON WAS INFLATED TO REMOVE THE DEVICE. THE PROCEDURE WAS COMPLETED WITH A NON BSC DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741646 FLEXTOME¿ CUTTING BALLOON¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS NWX BOSTON SCIENTIFIC - GALWAY H749RB4325100 0019203503

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention