BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING

    MDR report key: 10122507 · Received June 5, 2020

    Report

    Report Number
    2134265-2020-07581
    Event Type
    Malfunction
    Date Received
    June 5, 2020
    Date of Event
    June 1, 2020
    Report Date
    June 11, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LIT
    UDI-DI
    08714729845492
    PMA / PMN Number
    K132430
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    E1 INITIAL REPORTER CITY: MATSUMOTO CITY NAGANO PREFECTURE 3900852 UPDATED B5: DESCRIBE EVENT OR PROBLEM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 6.0X220X90-HYBRID STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED. IT WAS FURTHER REPORTED THAT THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 6 ATMOSPHERES. THE DEVICE WAS REMOVED INTACT.

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 6.0X220X90-HYBRID STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586169 STERLING CATHETER, PERCUTANEOUS LIT BOSTON SCIENTIFIC CORPORATION 24716 0023547957 08714729845492

    Patients

    Seq Age Sex Outcome Treatment
    1