BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENEGADE¿ HI-FLO¿ FATHOM¿ KIT

    MDR report key: 1771668 · Received July 27, 2010

    Report

    Report Number
    2134265-2010-03274
    Event Type
    Malfunction
    Date Received
    July 27, 2010
    Date of Event
    June 29, 2010
    Report Date
    June 29, 2010
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRA
    PMA / PMN Number
    K100892
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE RETURNED DEVICE WAS RECEIVED WITH THE GUIDE WIRE INSIDE THE SHAFT AND WAS UNABLE TO BE REMOVED. VISUAL AND MICROSCOPIC EXAMINATIONS REVEALED A BREAK 29.7CM FROM THE PROXIMAL END WITH 5CM OF BRAID EXPOSED. A STRETCHED AREA OF SHAFT WAS ALSO NOTED MEASURING 12.5CM. BLOOD WAS VISIBLE WITHIN THE DISTAL SHAFT. ALL DIMENSIONS WHICH WERE ABLE TO BE MEASURED WERE FOUND TO BE WITHIN SPECIFICATION. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS USER RELATED AS CONTINUOUS FLUSHING WAS NOT MAINTAINED IN THE PROCEDURE AS DIRECTED BY THE DFU. (B)(4).

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT:(B)(6). DEVICE RETURNED TO MFR: 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 AN UNSPECIFIED PROCEDURE, A SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE TORTUOUS AND SEVERELY CALCIFIED POPLITEAL ARTERY. THE RENEGADE HI-FLO CATHETER WAS POSITIONED IN THE VESSEL WITH SOME DIFFICULTY DUE TO THE PATIENTS ANATOMY. DYE HAD BEEN INJECTED THROUGH THE MICROCATHETER. AS THE PHYSICIAN TORQUED AND THEN DREW BACK ON THE CATHETER, THE SHAFT OF THE DEVICE BECAME SEPARATED IN ITS MID PORTION AND THE INTERNAL BRAID UNWOUND. THE ENTIRE SYSTEM WAS ABLE TO BE REMOVED AND THE PROCEDURE WAS COMPLETED WITH A NON BSC DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, A SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE TORTUOUS AND SEVERELY CALCIFIED POPLITEAL ARTERY. THE RENEGADE HI-FLO CATHETER WAS POSITIONED IN THE VESSEL WITH SOME DIFFICULTY DUE TO THE PATIENTS ANATOMY. DYE HAD BEEN INJECTED THROUGH THE MICROCATHETER. AS THE PHYSICIAN TORQUED AND THEN DREW BACK ON THE CATHETER, THE SHAFT OF THE DEVICE BECAME SEPARATED IN ITS MID PORTION AND THE INTERNAL BRAID UNWOUND. THE ENTIRE SYSTEM WAS ABLE TO BE REMOVED AND THE PROCEDURE WAS COMPLETED WITH A NON BSC DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENEGADE¿ HI-FLO¿ FATHOM¿ KIT RENEGADE HI-FLO FATHOM KIT KRA BOSTON SCIENTIFIC - CORK M001184620 13447217

    Patients

    Seq Age Sex Outcome Treatment
    1