BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OUTBACK RE-ENTRY CATHETER

    MDR report key: 3657984 · Received March 4, 2014

    Report

    Report Number
    9616099-2014-00159
    Event Type
    Injury
    Date Received
    March 4, 2014
    Date of Event
    December 27, 2013
    Report Date
    February 9, 2014
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQY
    PMA / PMN Number
    K043534
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS EVENT WAS REPORTED TO CORDIS THROUGH A VOLUNTARY MEDWATCH (3500A) REPORT. THE UF/IMPORTER # IS (B)(4). A COPY OF THE REPORT IS ATTACHED TO THIS MEDWATCH. THE DEVICE FOR THIS COMPLAINT IS NOT AVAILABLE FOR ANALYSIS. A DEVICE HISTORY RECORD (DHR) REVIEW AND ADDITIONAL INFORMATION ARE PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: REPORT RECEIVED VIA VOLUNTARY MEDWATCH INDICATED THAT DURING USE OF AN OUTBACK LTD RE-ENTRY CATHETER, ¿A SMALL FRAGMENT OF THE CATHETER TIP CAME APART AND LODGED ITSELF INTO AORTIC PLAQUE¿. THE SURGICAL TEAM WAS ABLE TO VISUALIZE FRAGMENT UNDER FLUOROSCOPY. THE REPORT INDICATED THAT THE SURGEON STATED THERE WAS NO NEED TO RETRIEVE FRAGMENT. MULTIPLE ATTEMPTS TO OBTAINED DETAILED PROCEDURAL INFORMATION ABOUT THE EVENT WERE UNSUCCESSFUL. THE PRODUCT WAS NOT RETURNED FOR EVALUATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THESE LOTS OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. THE IFU CONTAINS THE FOLLOWING PRECAUTIONS: IF STRONG RESISTANCE IS FELT DURING CATHETER MANIPULATION/DELIVERY, DETERMINE THE CAUSE OF THE RESISTANCE BEFORE PROCEEDING FURTHER. EXCESSIVE ROTATION, BENDING OR KINKING OF THE OB-LTD MAY AFFECT ITS PERFORMANCE. WITHDRAW THE OB-LTD IF IT BECOMES EXCESSIVELY KINKED. THE IFU INCLUDES TO ALWAYS VISUALIZE TRACKING OF THE CATHETER TIP OVER THE AORTO-ILIAC BIFURCATION IN THE PRECAUTIONS SECTION. TRACKING THE OUTBACK THROUGH AN ACUTE VESSEL ANGLE, SUCH AS THE AORTO-ILIAC BIFURCATION, MAY CONTRIBUTE TO THE EVENTS REPORTED. THE FAILURE CATHETER TIP/DISTAL TIP FRACTURED-SEPARATED/IN PATIENT REPORTED BY THE CUSTOMER WAS CONFIRMED. THE CAUSE OF THE FAILURE EXPERIENCED WAS NOT DETERMINED; INNER LINER PRESENT MARKS OF WELDING. THE EXACT CAUSE OF KINK IN THE CANNULA COULD BE NOT DETERMINED. CONTROLS ARE IN PLACE TO PREVENT DEFECTIVE CANNULA DAMAGED FROM LEAVING THE FACILITY. BASED ON THE LIMITED INFORMATION AVAILABLE FOR REVIEW AND WITHOUT THE PRODUCT AVAILABLE FOR ANALYSIS, THE REPORTED CUSTOMER COMPLAINT COULD NOT BE CONFIRMED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. A RISK ASSESSMENT AND A THOROUGH INVESTIGATION HAS PREVIOUSLY BEEN CONDUCTED REGARDING SEPARATION OF DISTAL TIPS FOR THE OUTBACK CTO CATHETER WHICH DETERMINED THAT THERE IS NO MANUFACTURING RELATED CAUSE RELATED TO SEPARATION OF THE DISTAL TIP. NOTIFICATION TO CUSTOMERS OF POST MARKET SURVEILLANCE DATA FOR THIS FAILURE HAS BEEN INITIATED AS WELL AS RECOMMENDATION TO ADHERE TO PROCEDURAL STEPS AND OBSERVATION OF PRECAUTIONS OUTLINED IN THE PRODUCT¿S IFU. NO ADDITIONAL ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    REPORT RECEIVED VIA VOLUNTARY MEDWATCH: (B)(4): DURING USE OF AN OUTBACK LTD RE-ENTRY CATHETER, IT WAS REPORTED THAT DURING USE A SMALL FRAGMENT OF THE CATHETER TIP CAME APART AND LODGED ITSELF INTO AORTIC PLAQUE. THE SURGICAL TEAM WAS ABLE TO VISUALIZE FRAGMENT UNDER FLUOROSCOPY. SURGEON STATES NO NEED TO RETRIEVE FRAGMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129146 OUTBACK RE-ENTRY CATHETER CTO CATHETER SYSTEMS (DQY) DQY CORDIS DE MEXICO NA 15725768

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Life Threatening| S