BEUDAMED
    FDA Adverse Event Death Summary report: N

    XXL BALLOON DILATATION CATHETER

    MDR report key: 2871730 · Received December 13, 2012

    Report

    Report Number
    2134265-2012-07578
    Event Type
    Death
    Date Received
    December 13, 2012
    Date of Event
    November 16, 2012
    Report Date
    November 16, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K952063
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: (B)(6). DEVICE EVALUATED BY MFR: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    SAME PATIENT AS MDR ID 2134265-2012-07579 AND 2134265-2012-07580. IT WAS REPORTED THAT DURING AN STENTING TREATMENT PROCEDURE PULMONARY EMBOLISM AND PATIENT DEATH OCCURRED. THE TARGET LESION WAS AN AREA OF STENOSIS IN THE SUPERIOR VENA CAVA (SVC). THE LESION WAS PREDILATED WITH A XXL BALLOON. A 20X4MM WALLSTENT WAS IMPLANTED IN THE SVC. THE STENT WAS WELL APPOSED. THERE WAS A LOT OF VISUAL THROMBUS NOTED. A SECOND XXL BALLOON WAS INFLATED. AGAIN, LARGE THROMBUS WAS SEEN IN THE SVC; ALTHOUGH, HEAVY THROMBUS BURDEN WAS NOTED 'EVERYWHERE' IN THE SVC. FOLLOWING THE SECOND BALLOON DILATION, THE PATIENT'S BLOOD PRESSURE DROPPED. THE PHYSICIAN BELIEVES THROMBUS TRAVELED TO THE LUNGS RESULTING IN PULMONARY EMBOLISM. CPR PERFORMED FOR APPROXIMATELY 45 MINUTES. THE PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XXL BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY UNK487

    Patients

    Seq Age Sex Outcome Treatment
    1 Death