BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL PERIPHERAL CUTTING BALLOON¿

    MDR report key: 6181790 · Received December 16, 2016

    Report

    Report Number
    2134265-2016-11689
    Event Type
    Malfunction
    Date Received
    December 16, 2016
    Date of Event
    September 8, 2016
    Report Date
    December 2, 2016
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NWX
    PMA / PMN Number
    P950020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MFR: THE DEVICE WAS RETURNED FOR ANALYSIS. THE DEVICE WAS RECEIVED IN TWO SECTIONS DUE TO A BREAK IN THE HYPOTUBE AT 57.8CM DISTAL TO THE STRAIN RELIEF. BOTH SECTIONS OF THE HYPOTUBE WERE KINKED. NO ISSUES WERE NOTED WITH THE DISTAL EXTRUSION. A MICROSCOPIC EXAMINATION OF THE BALLOON MATERIAL IDENTIFIED A PINHOLE IN THE BALLOON MATERIAL OVER THE DISTAL MARKERBAND. NO DAMAGE WAS NOTED TO THE DISTAL MARKERBAND OR BLADES. THE SHAFT DAMAGE NOTED DURING ANALYSIS IS CONSISTENT WITH EXCESSIVE FORCE HAVING BEEN APPLIED TO THE DEVICE. BASED ON THE ANALYSIS, THERE IS NO EVIDENCE HOWEVER THAT THE DEVICE FAILED TO MEET SPECIFICATION PRIOR TO SHIPPING. 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

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 02-DEC-2016. IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOTED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED POPLITEAL ARTERY. A 4.00MM X 1.5CM X 140CM SMALL PERIPHERAL CUTTING BALLOON¿ WAS SELECTED FOR USE. DURING PROCEDURE AT FIRST INFLATION AT 6 ATMOSPHERES AND 30 SECONDS, IT WAS NOTICED THAT THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD. HOWEVER, DEVICE ANALYSIS REVEALED A BREAK IN THE HYPOTUBE AT 57.8CM DISTAL TO THE STRAIN RELIEF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831997 SMALL PERIPHERAL CUTTING BALLOON¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS NWX BOSTON SCIENTIFIC - GALWAY M001BPM4015140F0 18890024

    Patients

    Seq Age Sex Outcome Treatment
    1