BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUBICON¿ 18

    MDR report key: 3021446 · Received March 26, 2013

    Report

    Report Number
    2134265-2013-01689
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    February 25, 2013
    Report Date
    February 25, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K122394
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: OVER (B)(6). (B)(4). DEVICE EVALUATION 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BALLOON ANGIOPLASTY TREATMENT PROCEDURE, THE CATHETER BECAME FROZEN ON THE GUIDE WIRE. THE TARGET LESION WAS LOCATED IN THE DISTAL SUPERFICIAL FEMORAL ARTERY. INITIALLY, THE .018 RUBICON SUPPORT CATHETER WAS UTILIZED WITH A V-18 GUIDE WIRE WITHOUT DIFFICULTIES. HOWEVER, WHEN THE PHYSICIAN EXCHANGED TO A VICTORY GUIDE WIRE, THE CATHETER AND GUIDE WIRE BECAME STUCK. BOTH DEVICES WERE REMOVED AS A UNIT, AND TE PROCEDURE WAS COMPLETED WITH AN UNSPECIFIED DIAGNOSTIC CATHETER AND 5F GUIDE WIRE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS WAS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122969 RUBICON¿ 18 CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE UNK756

    Patients

    Seq Age Sex Outcome Treatment
    1