BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OUTBACK RE-ENTRY CATHETER

    MDR report key: 1470030 · Received July 30, 2009

    Report

    Report Number
    9616099-2009-01266
    Event Type
    Malfunction
    Date Received
    July 30, 2009
    Date of Event
    July 17, 2009
    Report Date
    July 17, 2009
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQY
    PMA / PMN Number
    K043534
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT AVAILABLE FOR ANALYSIS. A REVIEW OF THE MFG ROUTE SHEETS FOR THE INVOLVED LOT CONFIRMED THAT THE DEVICE MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. THE COMPLAINT OF DISTAL TIP SEPARATION WAS INVESTIGATED. THERE IS NO EVIDENCE OF MFG OR DESIGN ISSUES THAT CONTRIBUTED TO THE EVENT. INSPECTIONS ARE IN PLACE TO ENSURE THAT NO DAMAGED PRODUCTS LEAVE THE FACILITY. REVIEW OF THE INFO SUGGESTS THAT VESSEL, LESION, PROCEDURAL AND HANDLING ISSUES MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    THE COMPLAINT RECEIVED STATES THAT DURING AN INTERVENTIONAL PROCEDURE, THE DISTAL TIP OF AN OUTBACK LTD CATHETER SEPARATED AND WAS RETAINED IN THE PT. A MALE PT (AGE AND MEDICAL HISTORY UNK) WAS ADMITTED FOR ABDOMINAL AORTIC ANEURYSM (AAA) REPAIR. ACCESS TO THE AORTA WAS NOT POSSIBLE DUE TO A CHRONIC TOTAL OCCLUSION IN THE RIGHT ILIAC. AN OUTBACK CATHETER WAS USED TO ATTEMPT TO CROSS THE LESION, BUT THE OUTBACK NEEDLE WAS NOT LONG ENOUGH TO REACH THE AORTA AND REPEATEDLY ENDED UP IN THE LEFT ILIAC. DUE TO THE EXCESSIVE TORQUING TO TRY TO REACH THE AORTA, THE TIP OF THE OUTBACK SEPARATED AND WAS RETAINED WITHIN THE PT. THERE WERE NO ATTEMPTS TO RETRIEVE THE SMALL DISTAL TIP SINCE IT WAS IN AN AREA OF NO BLOOD FLOW AND "COULD NOT CAUSE HARM TO THE PT". THERE WERE NO FURTHER ATTEMPTS TO CROSS THE LESION AND THE AAA REPAIR WAS NOT PERFORMED. THE DEVICE HAD BEEN PREPPED ACCORDING TO IFU AND APPEARED NORMAL PRIOR TO USE. THE PHYSICIAN FELT THAT THE CAUSE OF THE TIP SEPARATION WAS THE EXCESSIVE TORQUING AND THAT THERE WAS NO OUTBACK MALFUNCTION. THE OUTBACK UNIT WAS DISCARDED AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OUTBACK RE-ENTRY CATHETER CTO CATHETER SYSTEM (DQY) DQY CORDIS DE MEXICO NA 14063322

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK