BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING?

    MDR report key: 4192692 · Received October 22, 2014

    Report

    Report Number
    2134265-2014-06633
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 9, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LIT
    PMA / PMN Number
    K132430
    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 COMPLAINT DEVICE WAS NOT RECEIVED FOR 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT SIDE OF FEMORAL ARTERY THROUGH A 6F 50CM NON BSC SHEATH. THE 99 % IN STENT RE-STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY (SFA). AFTER A NON BSC GUIDE WIRE CROSSED THE LESION, A 5.0X220X90 STERLING¿ BALLOON CATHETER WAS ADVANCED. DURING THE FIRST INFLATION AT 5ATMS, THE BALLOON RUPTURED AFTER 5 SECONDS. IT WAS NOTED THAT THERE WAS A LEAKAGE OF CONTRAST MEDIA UNDER FLUOROSCOPY. THERE WAS NO KINK PRIOR TO USE AND NO RESISTANCE NOTED DURING THE PROCEDURE. THE BALLOON WAS COMPLETELY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672963 STERLING? CATHETER, PERCUTANEOUS LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939032502290 16753720

    Patients

    Seq Age Sex Outcome Treatment
    1 6F 50CM DESTINATION (TERUMO): SHEATH| CRUISE(ST.JUDE MEDICAL): GUIDE WIRE