BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING?

    MDR report key: 3963104 · Received July 29, 2014

    Report

    Report Number
    2134265-2014-04363
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K053118
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID 2134265-2014-04357. IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 6.0MMX40MMX135CM STERLING¿ BALLOON CATHETER WAS ADVANCED TO DILATE AN UNSPECIFIED PREVIOUSLY IMPLANTED STENT. THE BALLOON WAS INFLATED HOWEVER IT RUPTURED AT 8 ATMOSPHERES ON THE FIRST INFLATION. THEN ANOTHER 6.0MMX40MMX135CM STERLING¿ BALLOON CATHETER WAS ADVANCED; HOWEVER, THE BALLOON AGAIN RUPTURED AT 8 ATMOSPHERES ON THE FIRST INFLATION. NO SEGMENT OF THE TWO BALLOONS WAS DETACHED INSIDE THE PATIENT AFTER THEY RUPTURED AND BOTH DEVICES WERE ABLE TO BE REMOVED COMPLETELY FROM THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441083 STERLING? CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H74939031604010 16863990

    Patients

    Seq Age Sex Outcome Treatment
    1