BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    F/G RENEGADE 150/10/2TIP

    MDR report key: 2942699 · Received February 4, 2013

    Report

    Report Number
    3008853977-2013-00015
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 28, 2013
    Manufacturer
    BOSTON SCIENTIFIC CORK, LTD
    Product Code
    KRA
    PMA / PMN Number
    K973645
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. ANALYSIS REVEALED THAT THE SHAFT WAS SEPARATED AT 8.4CM, AND FLATTENING OF THE TIP WAS OBSERVED. STRETCHING AT EITHER END OF THE BREAK AREA WAS OBSERVED; INDICATIVE THAT FORCE WAS APPLIED. INFORMATION AVAILABLE INDICATED THAT RESISTANCE WAS EXPERIENCED UPON REMOVAL OF THE DEVICE FROM THE DISPENSER HOOP. THE DEVICE DIRECTIONS FOR USE (DFU) INSTRUCT TO: REPEAT INJECTION IF DIFFICULT REMOVAL OF THE MICRO CATHETER OCCURS." THIS ENSURES THAT IF DIFFICULTY IS EXPERIENCED ON REMOVING THE CATHETER TO CONTINUE FLUSHING, THIS PREVENTS ANY DAMAGE/BREAKAGES OCCURRING ON REMOVAL FROM THE HOOP. IT IS PROBABLE THAT FORCE EXERTED UPON ENCOUNTERING RESISTANCE DURING REMOVAL OF THE DEVICE FROM THE DISPENSER HOOP RESULTED IN THE REPORTED ISSUE. THEREFORE, A ROOT CAUSE OF HANDLING DAMAGE WILL BE ASSIGNED TO THIS INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4): DEVICE IS NOT AVAILABLE TO THE MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE REMOVAL OF THE DEVICE FROM THE DISPENSER HOOP THE CATHETER SHAFT BROKE AND THE DISTAL END REMAINED WITHIN THE DISPENSER HOOP. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE REMOVAL OF THE DEVICE FROM THE DISPENSER HOOP THE CATHETER SHAFT BROKE AND THE DISTAL END REMAINED WITHIN THE DISPENSER HOOP. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46924 F/G RENEGADE 150/10/2TIP CATHETER, CONTINUOUS FLUSH KRA BOSTON SCIENTIFIC CORK, LTD 14989257

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR