BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY BALLOON DILATATION CATHETER

    MDR report key: 4132926 · Received October 1, 2014

    Report

    Report Number
    2134265-2014-05998
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Report Date
    September 8, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K993305
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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. LITERATURE CITATION: "PROSPECTIVE, RANDOMIZED STUDY OF CUTTING BALLOON ANGIOPLASTY VERSUS CONVENTIONAL BALLOON ANGIOPLASTY FOR THE TREATMENT OF HEMODIALYSIS ACCESS STENOSES; JOURNAL OF VASCULAR SURGERY; 2014" (B)(4).

    Description of Event or Problem · 1

    REPORTED VIA JOURNAL ARTICLE: IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. IN A STUDY COMPARING RATES OF PATENCY ACHIEVED BY CUTTING AND CONVENTIONAL BALLOON ANGIOPLASTY TO TREAT HEMODIALYSIS ACCESS STENOSES, A BALLOON RUPTURE DURING INFLATION OCCURRED IN THE CONVENTIONAL BALLOON ANGIOPLASTY GROUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613281 SYNERGY BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY UNK425

    Patients

    Seq Age Sex Outcome Treatment
    1