BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL PERIPHERAL CUTTING BALLOON¿

    MDR report key: 2914760 · Received January 14, 2013

    Report

    Report Number
    2134265-2012-08397
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    November 21, 2012
    Report Date
    December 16, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LOX
    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. DEVICE EVALUATED BY MFR.: BLOOD WAS PRESENT WITHIN THE BALLOON WHICH IS EVIDENCE OF A LEAK. BALLOON MATERIAL WAS RAISED 2.5CM IN THE MID BALLOON BODY. A LEAK WAS PRESENT AT THIS LOCATION ALSO. THE SHAFT WAS KINKED 28.3CM AND 29.3CM FROM THE CATHETER TIP. THIS IS CONSISTENT WITH APPLIED FORCES TO THE DEVICE DURING THE PROCEDURE/HANDLING. A PARTIAL BLADE DETACHMENT WAS ALSO NOTED. APPROXIMATELY 1MM OF BLADE HAD DETACHED IN THE MID BALLOON BODY. THE PAD WAS INTACT. THE REMAINING BALLOON AND TIP SECTIONS OF THE DEVICE WERE MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH THEIR PROFILES. ALL REMAINING BLADES WERE PRESENT AND FULLY BONDED TO THE BALLOON SURFACE. 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 PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    COMPLAINT IS REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6) 2012. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE, CROSSING DIFFICULTY OCCURRED. ACCESS WAS OBTAINED VIA THE LEFT FEMORAL ARTERY. THE 95% STENOSED LESION WAS LOCATED IN THE CALCIFIED AND MODERATELY TORTUOUS DISTAL PORTION OF THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). THE 3.50MM/1.5CM/140CM SMALL FLEXTOME MR PERIPHERAL CUTTING BALLOON WAS UNABLE TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD. HOWEVER, RETURNED PRODUCT ANALYSIS REVEALED A PARTIAL BLADE DETACHMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20732 SMALL PERIPHERAL CUTTING BALLOON¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY M001BPM3515140F0 0014731306

    Patients

    Seq Age Sex Outcome Treatment
    1