BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OUTBACK RE-ENTRY CATHETER

    MDR report key: 2122202 · Received June 13, 2011

    Report

    Report Number
    9616099-2011-00412
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 20, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQY
    PMA / PMN Number
    K043534
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: AS REPORTED AN OUTBACK CATHETER FRACTURED AT THE DISTAL END AND AN AVIATOR BALLOON RUPTURED AND ONLY PARTIALLY DEFLATED. THE OUTBACK WAS ADVANCED INTO THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) THROUGH A 6F COOK ANSEL SHEATH. THE PATIENT'S VESSELS WERE EXTREMELY CALCIFIED AND THE AORTIC BIFURCATION WAS STEEP. THERE WAS SOME DIFFICULTY IN ADVANCING THE OUTBACK INTO POSITION, BUT THE NEEDLE WAS DEPLOYED SUCCESSFULLY AND THE CHRONIC TOTAL OCCLUSION (CTO) WAS CROSSED. UPON RETRACTING THE OUTBACK, THERE WAS SIGNIFICANT RESISTANCE AS THE DISTAL NEEDLE HOUSING REACHED THE AORTIC BIFURCATION, AND THERE WAS DIFFICULTY CROSSING OVER THE BIFURCATION; HOWEVER, THE OUTBACK EVENTUALLY CAME FREE AND WAS ABLE TO BE RETRACTED OUT OF THE SHEATH. AS THE TIP OF THE OUTBACK CAME THROUGH THE SHEATH, IT WAS NOTED THAT THE DISTAL TIP HAD SEPARATED AND THE INNER METAL COIL WAS EXPOSED (THE TIP WAS CONNECTED BY AN INTERNAL COIL FROM WITHIN THE SHAFT). THE ENTIRE DEVICE WAS ABLE TO BE REMOVED WITH NO PATIENT INJURY. DURING ANGIOPLASTY OF AN ILIAC LESION DURING THE SAME PROCEDURE, AN AVIATOR BALLOON RUPTURED LONGITUDINALLY AT 4 ATMOSPHERES. IT WAS REPORTED THAT THERE WAS HIGHLY CALCIFIED ILIAC PLAQUE. THE BALLOON DID NOT RE-WRAP PROPERLY AND ONLY PARTIALLY DEFLATED CAUSING MINOR RESISTANCE WHILE BEING REMOVED FROM THE SHEATH. THE DEVICE WAS NOT FLOW LIMITING AND THERE WAS NO PATIENT INJURY. ISOVUE 300 CONTRAST WAS USED FOR THE PROCEDURE WITH (B)(4). A SECOND AVIATOR BALLOON WAS USED TO COMPLETE THE PROCEDURE WITHOUT INCIDENT. ONE NON STERILE OUTBACK WAS RECEIVED COILED INSIDE TWO PLASTIC BAGS. A KINK WAS FOUND IN THE DISTAL TIP, ALSO DISTAL END WAS FOUND SEPARATED AND TWISTED. NO OTHER DAMAGES WERE NOTED. DURING THE MICROSCOPIC ANALYSIS, THE SHAFT WAS FOUND DAMAGED. 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 TRACKING DIFFICULTY COULD NOT BE CONFIRMED DUE TO THE DISTAL TIP CONDITION. THE FAILURE REPORTED "WITHDRAWAL DIFFICULTY-FROM VESSEL AND FRACTURED IN PATIENT FAILURES WERE CONFIRMED. THE CAUSE OF THE FAILURE EXPERIENCED BY THE CUSTOMER COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE FAILURE. CONTROLS ARE IN PLACE TO PREVENT DEFECTIVE UNITS FROM LEAVING THE FACILITY. NEITHER THE ANALYSIS NOR THE DHR REVIEW SUGGESTS THAT THIS FAILURE IS RELATED TO THE MANUFACTURING PROCESS; THEREFORE NO ACTION WAS TAKEN. BASED ON THE INFORMATION AVAILABLE, IT APPEARS THAT THE DIFFICULTY EXPERIENCED BY THE CUSTOMER MAY HAVE BEEN CAUSED BY THE OPERATIONAL CONTEXT OF THE DEVICE, VESSEL CHARACTERISTICS AND/OR PROCEDURAL FACTORS. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2011-00412 AND 9616099-2011-00413. ONE NON STERILE OUTBACK WAS RECEIVED COILED INSIDE TWO PLASTIC BAGS. A KINK WAS FOUND IN THE DISTAL TIP, ALSO DISTAL END WAS FOUND SEPARATED AND TWISTED. NO OTHER DAMAGES WERE NOTED. DURING THE MICROSCOPIC ANALYSIS, THE SHAFT WAS FOUND DAMAGED. 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 TRACKING DIFFICULTY COULD NOT BE CONFIRMED DUE TO THE DISTAL TIP CONDITION. THE FAILURE REPORTED "WITHDRAWAL DIFFICULTY-FROM VESSEL AND FRACTURED IN PATIENT FAILURES WERE CONFIRMED. THE CAUSE OF THE FAILURE EXPERIENCED BY THE CUSTOMER COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE FAILURE. CONTROLS ARE IN PLACE TO PREVENT DEFECTIVE UNITS FROM LEAVING THE FACILITY. NEITHER THE ANALYSIS NOR THE DHR REVIEW SUGGESTS THAT THIS FAILURE IS RELATED TO THE MANUFACTURING PROCESS; THEREFORE NO ACTION WAS TAKEN.

    Additional Manufacturer Narrative · 1

    AS THE TIP OF THE OUTBACK CAME THROUGH THE SHEATH, IT WAS NOTED THAT THE DISTAL TIP HAD SEPARATED AND THE INNER METAL COIL WAS EXPOSED (THE TIP WAS CONNECTED BY AN INTERNAL COIL FROM WITHIN THE SHAFT). THE ENTIRE DEVICE WAS ABLE TO BE REMOVED AND NO HARM WAS DONE TO THE PATIENT. DURING ANGIOPLASTY OF AN ILIAC LESION DURING THE SAME PROCEDURE, AN AVIATOR BALLOON RUPTURED LONGITUDINALLY AT 4 ATMOSPHERES. IT WAS REPORTED THAT THERE WAS HIGHLY CALCIFIED ILIAC PLAQUE. THE BALLOON DID NOT RE-WRAP PROPERLY AND ONLY PARTIALLY DEFLATED CAUSING MINOR RESISTANCE WHILE BEING REMOVED FROM THE SHEATH. THE DEVICE WAS NOT FLOW LIMITING AND THERE WAS NO PATIENT INJURY. ISOVUE 300 CONTRAST WAS USED FOR THE PROCEDURE WITH 60% SALINE AND 40% CONTRAST. A SECOND AVIATOR BALLOON WAS USED TO COMPLETE THE PROCEDURE WITHOUT INCIDENT. THE DEVICE WAS RETURNED FOR ANALYSIS, BUT THE ANALYSIS HAS NOT YET BEEN COMPLETED. 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. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2011-00412 AND 9616099-2011-00413.

    Description of Event or Problem · 1

    AS REPORTED BY SALES REP, AN OUTBACK CATHETER FRACTURED AT THE DISTAL END AND AN AS REPORTED BY SALES REP, AN OUTBACK CATHETER FRACTURED AT THE DISTAL END AND AN AVIATOR BALLOON RUPTURED AND ONLY PARTIALLY DEFLATED. THE OUTBACK WAS ADVANCED INTO THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) THROUGH A 6F COOK ANSEL SHEATH. THE PATIENT'S VESSELS WERE EXTREMELY CALCIFIED AND THE AORTIC BIFURCATION WAS STEEP. THERE WAS SOME DIFFICULTY IN ADVANCING THE OUTBACK INTO POSITION, BUT THEY WERE ABLE TO DO SO. THE OUTBACK NEEDLE WAS DEPLOYED SUCCESSFULLY AND THE CHRONIC TOTAL OCCLUSION (CTO) WAS CROSSED. UPON RETRACTING THE OUTBACK, THERE WAS SIGNIFICANT RESISTANCE AS THE DISTAL NEEDLE HOUSING REACHED THE AORTIC BIFURCATION, AND THERE WAS DIFFICULTY CROSSING OVER THE BIFURCATION; HOWEVER, THE OUTBACK EVENTUALLY CAME FREE AND WAS ABLE TO BE RETRACTED OUT OF THE SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OUTBACK RE-ENTRY CATHETER CTO CATHETER SYSTEMS (DQY) DQY CORDIS DE MEXICO NA 15242059

    Patients

    Seq Age Sex Outcome Treatment
    1 6F COOK ANSEL SHEATH