BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XXL BALLOON DILATATION CATHETER

    MDR report key: 2061599 · Received April 18, 2011

    Report

    Report Number
    2134265-2011-01178
    Event Type
    Injury
    Date Received
    April 18, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 22, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K952063
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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; 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 CAN NOT BE REVIEWED. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.(B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ANGIOPLASTY TREATMENT PROCEDURE, A BALLOON RUPTURED OCCURRED. THE 75-80% STENOTIC LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON CALCIFIED PROXIMAL SUPERIOR VENA CAVA ARTERY (SVC). THE PHYSICIAN ADVANCED THE 16-4/5.8/75 XXL BALLOON TO THE LESION AND ON THE FIRST INFLATION, INFLATED THE BALLOON TO 6 TO 8ATMS FOR ONE TO TWO SECONDS AND THE BALLOON RUPTURED. THE RUPTURE OCCURRED AT THE LEVEL OF THE RIGHT INNOMINATE VEIN AND THE TARGET LESION. DURING WITHDRAWAL, THE BALLOON GOT CAUGHT ON THE SHEATH AND SHEARED A PIECE OF THE BALLOON OFF. THE PHYSICIAN RETRIEVED THE FRAGMENT. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, TWELVE DAYS POST PROCEDURE THE PATIENT PRESENTED WITH RECURRENT FACIAL SWELLING AND IT WAS DISCOVERED BY CT SCAN THAT THERE WAS A FRAGMENT AT THE LEVEL OF HIS SVC STENOSIS. THE FRAGMENT WAS RETRIEVED VIA THE COMMON FEMORAL VEIN WITH A SNARE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XXL BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY M001145520

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention