BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENEGADE¿ STC 18

    MDR report key: 2770703 · Received October 3, 2012

    Report

    Report Number
    2134265-2012-06198
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Date of Event
    September 6, 2012
    Report Date
    September 6, 2012
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    DQO
    PMA / PMN Number
    K023681
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE MICROCATHETER WAS VISUALLY EXAMINED AND NO ANOMALIES WERE NOTED. DIMENSIONAL MEASUREMENTS WERE TAKEN AND MET SPECIFICATIONS. DURING FUNCTIONAL TESTING A 0.0184'' MANDREL WAS INSERTED THROUGH THE PROXIMAL END OF THE CATHETER AND IT WAS ADVANCED THROUGH THE CATHETER SHAFT AND OUT THE DISTAL END WITHOUT RESTRICTION. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL AND/OR PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, 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 EMBOLIZATION TREATMENT PROCEDURE, CATHETER FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A SEVERELY TORTUOUS ARTERY. THIS RENEGADE MICROCATHETER WAS SELECTED ALONG WITH A NON-BSC .018 COIL. THE PHYSICIAN STATED THAT THE .018 NON-BSC PUSHING COIL WAS DIFFICULT TO PASS AFTER THE THIRD ONE AND THE INNER LUMEN OF THE CATHETER BROKE, BUT THE DELAMINATED MATERIAL DID NOT DETACH FROM THE CATHETER. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A EMBOLIZATION TREATMENT PROCEDURE, CATHETER FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A SEVERELY TORTUOUS ARTERY. THIS RENEGADE MICROCATHETER WAS SELECTED ALONG WITH A NON-BSC .018 COIL. THE PHYSICIAN STATED THAT THE .018 NON-BSC PUSHING COIL WAS DIFFICULT TO PASS AFTER THE THIRD ONE AND THE INNER LUMEN OF THE CATHETER BROKE, BUT THE DELAMINATED MATERIAL DID NOT DETACH FROM THE CATHETER. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENEGADE¿ STC 18 CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO BOSTON SCIENTIFIC - CORK M001181320 14888872

    Patients

    Seq Age Sex Outcome Treatment
    1