BEUDAMED
    FDA Adverse Event Death Summary report: N

    STERLING BALLOON DILATATION CATHETER

    MDR report key: 3052099 · Received April 11, 2013

    Report

    Report Number
    2134265-2013-02859
    Event Type
    Death
    Date Received
    April 11, 2013
    Report Date
    April 2, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K053118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: CARDAIOLI, PAOLO. ET AL. (2011). ENDOVASCULAR TREATMENT OF DIABETIC FOOT SYNDROME: RESULTS FROM A SINGLE CENTER PROSPECTIVE REGISTRY USING MIXED CORONARY AND PERIPHERAL TECHNIQUES AND EQUIPMENT. THE JOURNAL OF INTERVENTIONAL CARDIOLOGY. VOL. 24, NO. 6, 2011. 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. THE BATCH NUMBER IS UNKNOWN; THEREFORE THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE CANNOT BE REVIEWED. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS 2134265-2013-02876. IT WAS REPORTED VIA A JOURNAL ARTICLE THAT DURING THE TREATMENT OF ENDOVASCULAR DIABETIC FOOT SYNDROME V-18 GUIDEWIRES AND STERLING BALLOONS WERE USED ALONG WITH NON-BSC DEVICES. ONE PATIENT SUFFERED FROM A MAJOR COMPLICATION AND DIED IN THE HOSPITAL DUE TO A RETROPERITONEAL HEMATOMA. GROIN HEMATOMAS OCCURRED IN THREE PATIENTS, PUNCTURE SITE PSEUDOANEURYSM OCCURRED IN TWO PATIENTS, ARTERIOVENOUS FISTULA OCCURRED IN ONE PATIENT AND VESSEL RUPTURE OCCURRED IN FIVE PATIENTS. IT IS UNKNOWN IF THE BSC DEVICES CAUSED OR CONTRIBUTED TO ANY OF THESE ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156936 STERLING BALLOON DILATATION CATHETER CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE UNK413

    Patients

    Seq Age Sex Outcome Treatment
    1 Other