BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OUTBACK RE-ENTRY CATHETER

    MDR report key: 3213868 · Received July 9, 2013

    Report

    Report Number
    9616099-2013-00434
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 18, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQY
    PMA / PMN Number
    K043534
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE ADVANCING THE OUTBACK TO THE TARGET LESION, IT WAS INITIALLY REPORTED THAT THE TIP BROKE AT THE TOP OF THE BIFURCATION INSIDE OF THE GUIDING SHEATH. THE WHOLE SYSTEM (CATHETER, SHEATH AND BROKEN CATHETER TIP) WAS RETRIEVED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. HOWEVER, UPON RETURN OF THE DEVICE FOR ANALYSIS, THE DISTAL TIP WAS FOUND INTACT AND THE SHAFT WAS FOUND SEPARATED IN THE DISTAL END. THE TARGET LESION WAS A SUPERFICIAL FEMORAL ARTERY (SFA) OCCLUSION VIA A CROSSOVER TECHNIQUE. THERE WERE NO ANOMALIES NOTICED DURING PREPARATION OF THE CATHETER. A NON-CORDIS GUIDING SHEATH WAS PLACED THROUGH THE AORTIC BIFURCATION. WHILE ADVANCING THE OUTBACK TO THE TARGET LESION THE TIP BROKE AT THE TOP OF THE BIFURCATION INSIDE OF THE GUIDING SHEATH. THE BROKEN TIP COULD BE REMOVED WITH THE GUIDING SHEATH SUCCESSFULLY. THE PRODUCT WAS RETURNED FOR INSPECTION. ONE NON-STERILE OUTBACK WAS RECEIVED COILED INSIDE TWO PLASTIC BAGS. THE SHAFT WAS FOUND SEPARATED AT 2.5 CM FROM DISTAL END. THE SHAFT WAS ELONGATED IN THE SEPARATION POINTS. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE REPORTED CATHETER TIP/DISTAL TIP (OUTBACK ONLY)/SEPARATED WAS NOT CONFIRMED SINCE THE TIP WAS ATTACHED TO THE CATHETER. THE EXACT CAUSE OF THE SEPARATION IN THE SHAFT COULD NOT BE DETERMINED, HOWEVER EVIDENCE OF ELONGATION IN THE EDGES INDICATES PULLING UNTIL THE POINT OF SEPARATION. CONTROLS ARE PLACED IN THE MANUFACTURING LINE TO PREVENT DEFECTIVE UNITS FROM LEAVING THE BUILDING; NEITHER THE ANALYSIS NOR THE DHR REVIEW SUGGESTS THAT THIS FAILURE IS RELATED TO THE MANUFACTURING PROCESS; THEREFORE NO ACTIONS WILL BE TAKEN.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS AVAILABLE FOR EVALUATION AND TESTING. HOWEVER, THE PRODUCT HAS NOT BEEN RETURNED AS OF TO DATE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT DURING AN ENDOVASCULAR PROCEDURE AS THE OUTBACK RE-ENTRY CATHETER WAS ADVANCED THROUGH THE NON-CORDIS GUIDING SHEATH, THE TIP OF THE CATHETER BROKE INSIDE OF THE GUIDING SHEATH. THE GUIDING SHEATH HAD BEEN PLACED OVER THE AORTIC BIFURCATION. THE WHOLE SYSTEM (CATHETER, SHEATH AND BROKEN CATHETER TIP) WAS RETRIEVED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THE TARGET LESION WAS A SUPERFICIAL FEMORAL ARTERY (SFA) OCCLUSION VIA A CROSSOVER TECHNIQUE. THERE WERE NO ANOMALIES NOTICED DURING PREPARATION OF THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313051 OUTBACK RE-ENTRY CATHETER CTO CATHETER SYSTEMS (DQY) DQY CORDIS DE MEXICO NA 15817163

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening COOK DESTINATION CROSSOVER GUIDNG SHEATH