BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUTTING BALLOON

    MDR report key: 4119465 · Received September 25, 2014

    Report

    Report Number
    2134265-2014-06183
    Event Type
    Injury
    Date Received
    September 25, 2014
    Report Date
    September 2, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K040155
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. JOURNAL ARTICLE: AFTAB, SYED ARAFAT ET. AL, ¿RANDOMIZED CLINICAL TRIAL OF CUTTING BALLOON ANGIOPLASTY VERSUS HIGH-PRESSURE BALLOON ANGIOPLASTY IN HEMODIALYSIS ARTERIOVENOUS FISTULA STENOSES RESISTANT TO CONVENTIONAL BALLOON ANGIOPLASTY¿, J VASC INTERV RADIOL 2014;25:190¿198. DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. 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

    REPORTED VIA JOURNAL ARTICLE. IT WAS REPORTED THAT A VENOUS RUPTURE OCCURRED. THE PATIENT UNDERWENT TREATMENT OF AN ARTERIOVENOUS FISTULA IN THE STENOSED CEPHALIC VEIN ARCH. FOLLOWING ANGIOPLASTY WITH AN UNSPECIFIED CUTTING BALLOON, THE PATIENT EXPERIENCED A VENOUS RUPTURE WITH ACTIVE EXTRAVASATION. TREATMENT WAS SUCCESSFULLY MANAGED WITH BALLOON TAMPONADE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597412 CUTTING BALLOON CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY UNK103

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention