BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OUTBACK RE-ENTRY CATHETER

    MDR report key: 1566796 · Received December 10, 2009

    Report

    Report Number
    9616099-2009-01829
    Event Type
    Malfunction
    Date Received
    December 10, 2009
    Date of Event
    November 18, 2009
    Report Date
    November 18, 2009
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQY
    PMA / PMN Number
    K043534
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. THE PRODUCT IS AVAILABLE FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    IT IS REPORTED THAT MARKER TIP OF THE OUTBACK CATHETER BROKE OFF INSIDE THE ANSEL SHEATH. THERE WAS COMPLETE SEPARATION OF THE TIP FROM THE CATHETER. THE TARGET LESION WAS THE DISTAL SFA. THE LESION WAS BIFURCATED. NO ANOMALIES WERE NOTED DURING PREP. NO EXCESSIVE FORCE WAS USED TO INSERT THE OUTBACK CATHETER IN THE ANSEL SHEATH. THE TIP SEPARATION OCCURRED INSIDE THE PATIENT. THERE WAS NO PATIENT INJURY AND NO ADDITIONAL INTERVENTION WAS REQUIRED. THE SHEATH WAS REMOVED WITH THE TIP STUCK INSIDE. THE SHEATH AND CATHETER TIP WILL BE RETURNED FOR ANALYSIS.

    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 14081368

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK