BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SI BRITE TIP

    MDR report key: 2925495 · Received January 22, 2013

    Report

    Report Number
    9616099-2013-00030
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 28, 2012
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DYB
    PMA / PMN Number
    K984500
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: DURING A PTA PROCEDURE, WHEN AN 8F BRITE TIP SHEATH WAS BEING INSERTED INTO THE PATIENT, THE DISTAL TIP OF THE INTRODUCER BECAME FRAYED. A DIFFERENT PRODUCT WAS USED SUCCESSFULLY. THERE WAS NO PATIENT INJURY REPORTED. THERE WAS NO EXCESSIVE TORQUE USED DURING INSERTION. THE DEVICE WAS PREPPED PER IFU INSTRUCTION. THERE IS NO INFORMATION AVAILABLE ON THE VESSEL/TARGET OR ON ITS CHARACTERISTICS. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS AS IT WAS DISCARDED AT THE HOSPITAL. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THESE LOTS OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. WITH THE LIMITED INFORMATION AVAILABLE, AND NO PRODUCT RETURN, THE COMPLAINT COULD NOT BE CONFIRMED AND NO DETERMINATION REGARDING POTENTIAL CONTRIBUTING FACTORS COULD BE MADE. HOWEVER, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS ARE MOST LIKELY CONTRIBUTING FACTORS TO THE FAILURE REPORTED. BASED ON THE DEVICE HISTORY RECORD REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME

    Description of Event or Problem · 1

    AS REPORTED BY AN AFFILIATE, DURING A PTA PROCEDURE, WHEN AN 8F BRITE TIP SHEATH WAS BEING INSERTED INTO THE PATIENT, THE DISTAL TIP OF THE INTRODUCER BECAME FRAYED. THE PHYSICIAN STOPPED USING THE BRITE TIP SHEATH AND A DIFFERENT PRODUCT WAS USED INSTEAD. THE PROCEDURE WAS FINISHED SUCCESSFULLY. THERE WAS NO PATIENT INJURY REPORTED. THERE WAS NO EXCESSIVE TORQUE USED DURING INSERTION. THE DEVICE WAS PREPPED PER IFU INSTRUCTION. THE COMPLAINT PRODUCT WILL NOT BE RETURNED FOR ANALYSIS AS IT WAS DISCARDED AT THE HOSPITAL. THERE IS NO INFORMATION AVAILABLE ON THE VESSEL/TARGET OR ON ITS CHARACTERISTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30707 SI BRITE TIP ENDOVASCULAR VASCULAR ACCESS (DYB) DYB CORDIS DE MEXICO NA 15653287

    Patients

    Seq Age Sex Outcome Treatment
    1