BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENEGADE FIBER BRAIDED MICROCATHETER

    MDR report key: 1933467 · Received December 20, 2010

    Report

    Report Number
    2134265-2010-05593
    Event Type
    Injury
    Date Received
    December 20, 2010
    Date of Event
    November 22, 2010
    Report Date
    November 24, 2010
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRA
    PMA / PMN Number
    K020012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. 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

    SAME CASE AS MDR #2134265-2010-05744, #2134265-2010-05745, #2134265-2010-05746 IT WAS REPORTED THAT DURING A CORONARY ARTERY TREATMENT PROCEDURE A VESSEL PERFORATION OCCURRED. THE LESION WAS LOCATED WITHIN THE VERY TORTUOUS AND CALCIFIED OBTUSE MARGINAL (OM) ARTERY. THE PHYSICIAN WAS ATTEMPTING TO WIRE THE LESION BUT ENCOUNTERED DIFFICULTY IN CROSSING THE LESION WITH EACH OF THE FOLLOWING GUIDE WIRES: 2 DIFFERENT NON-BSC GUIDE WIRES, ONE KINETIX GUIDE WIRE AND TWO PT FLOPPY GUIDE WIRES. A COUPLE UNKNOWN GUIDE WIRES WERE ABLE TO GO PAST THE LESION. THE PHYSICIAN ATTEMPTED TO ADVANCE A F/G RENEGADE 150/20/1TIP TO DO A WIRE EXCHANGE AND CREATED A DISSECTION. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE THE CATHETER PAST THE LESION. WHEN THE DEVICES WERE REMOVED, A PERFORATION ON THE OM WAS NOTICED. THE PATIENT WAS SENT TO SURGERY. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENEGADE FIBER BRAIDED MICROCATHETER CATHETER, CONTINUOUS FLUSH KRA BOSTON SCIENTIFIC - CORK M001182530

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention (2) PT FLOPPY GUIDE WIRES| KINETIX GUIDE WIRE| PROWATER GUIDE WIRE| WHISPER GUIDE WIRE