BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING¿

    MDR report key: 2873425 · Received December 14, 2012

    Report

    Report Number
    2134265-2012-07791
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    November 22, 2012
    Report Date
    November 22, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K053118
    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.: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, A BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA RIGHT FEMORAL ARTERY BY A CONTRALATERAL APPROACH. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS LEFT COMMON FEMORAL ARTERY. A .014 NON BSC GUIDE WIRE CROSSED THE LESION. THE 6.0 X 40 MM STERLING MR BALLOON CATHETER WAS INFLATED AND RUPTURED AT 14 ATMS ON THE 1ST INFLATION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERLING¿ CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H74939031604010 15482434

    Patients

    Seq Age Sex Outcome Treatment
    1 014 CRUISE: GUIDE WIRE