BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL PERIPHERAL CUTTING BALLOON¿

    MDR report key: 3030047 · Received April 2, 2013

    Report

    Report Number
    2134265-2013-01836
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    January 23, 2013
    Report Date
    March 5, 2013
    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. (B)(4). DEVICE EVALUATED BY MANUFACTURER: A VISUAL EXAMINATION IDENTIFIED A SHAFT BREAK 24.7CM FROM THE CATHETER TIP. THE BREAK WAS LOCATED AT THE EXCHANGE PORT AREA AND EVIDENCE OF STRETCHING WAS PRESENT. A VISUAL AND MICROSCOPIC EXAMINATION OBSERVED NO DAMAGE TO THE TIP, BALLOON, OR BLADES. ALL BLADES WERE PRESENT AND FULLY BONDED TO THE BALLOON SURFACE. NO KINKS OR DAMAGE WERE NOTED ALONG THE REMAINING SECTIONS OF THE DEVICE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS USER-RELATED AS THE DFU STATES 'CAUTION: USE ONLY A 6F (2.00 MM) OR LARGER INTRODUCER SHEATH.' HOWEVER, THE COMPLAINT STATES THAT A 4.5FR SHEATH WAS USED. (B)(4).

    Description of Event or Problem · 1

    THIS COMPLAINT IS NOW REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(4) 2013. IT WAS REPORTED THAT DURING A PERCUTANEOUS PERIPHERAL INTERVENTION, THE DEVICE WAS UNABLE TO CROSS THE LESION AND THE DEVICE WAS KINKED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE CALCIFIED AND MODERATELY TORTUOUS RIGHT SUPERFICIAL FEMORAL ARTERY. A NON-BSC INTRODUCER SHEATH AND NON-BSC GUIDE WIRE WERE ADVANCED TO THE TARGET LESION FROM THE LEFT SUPERFICIAL FEMORAL ARTERY. THE 4.00MM X 1.5CM X 140CM FLEXTOME SMALL PERIPHERAL CUTTING BALLOON WAS UNABLE TO CROSS THE LESION AND CAME IN CONTACT WITH AN IMPLANTED STENT. A NON-BSC SUPPORT WIRE WAS USED BUT THE DEVICE WAS AGAIN UNABLE TO CROSS THE LESION. DURING THE ATTEMPTS TO CROSS THE LESION THE DEVICE BECAME KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT CONDITION IS GOOD. RETURNED PRODUCT ANALYSIS REVEALED A SHAFT BREAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133801 SMALL PERIPHERAL CUTTING BALLOON¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY M001BPM4015140F0 15546947

    Patients

    Seq Age Sex Outcome Treatment
    1 4.5FR PARENT INTRODUCER SHEATH| CRUISE GUIDE WIRE| AGURU SUPPORT WIRE