BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XXL BALLOON DILATATION CATHETER

    MDR report key: 2111626 · Received June 2, 2011

    Report

    Report Number
    2134265-2011-02250
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    May 4, 2011
    Report Date
    May 5, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K952063
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH FILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A THROMBOSIS TREATMENT PROCEDURE REMOVAL DIFFICULTIES OCCURRED. ACCESS WAS OBTAINED VIA THE PATIENT'S EXISTING TPA INFUSION CATHETER IN THE RIGHT INTERNAL JUGULAR VEIN. THE TARGET LESIONS WERE CLOTS LOCATED IN THE PATIENT'S RIGHT FEMORAL, RIGHT EXTERNAL ILIAC, RIGHT COMMON ILIAC AND POPLITEAL VEINS. THE PATIENT ALSO HAD CLOT NOTED IN THE INFERIOR VENA CAVA. A NON-BSC .035 180 CM GUIDE WIRE WAS ADVANCED THROUGH AN UNSPECIFIED 7FR SHEATH. A (B)(4) WAS ADVANCED ACROSS THE WIRE TO THE RIGHT FEMORAL VEIN. THE BALLOON WAS INFLATED TO 8 ATMS FOR 30 SECONDS 4 TIMES. THE BALLOON WAS INFLATED ONE ADDITIONAL TIME TO 8 ATMS FOR 1 MINUTE. THE BALLOON WAS FULLY DEFLATED. DURING WITHDRAWAL, DIFFICULTIES WERE ENCOUNTERED IN THAT THE BALLOON BECAME CAUGHT IN THE INTERNAL JUGULAR VEIN AND WAS UNABLE TO BE REMOVED. THE PATIENT WENT TO SURGERY LATER THE SAME DAY WHERE THE BALLOON CATHETER WAS REMOVED. THE TPA INFUSION CATHETER REMAINED IN PLACE. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE. 14 DAYS LATER, A CHEST CT SCAN REVEALED RIGHT INTERNAL JUGULAR THROMBOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XXL BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY M001145100 0013672914

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention GLIDEWIRE