BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SI BRITE TIP

    MDR report key: 2007155 · Received March 4, 2011

    Report

    Report Number
    9616099-2011-00156
    Event Type
    Malfunction
    Date Received
    March 4, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 21, 2011
    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

    THE COMPLAINT RECEIVED STATES THAT DURING AN INVASIVE PROCEDURE THE BRITE TIP SHEATH HAD INSERTION DIFFICULTY AND THE TIP BECAME FRAYED. PTA WAS BEING PERFORMED ON A LESION IN THE LOWER LIMB WITH NO CALCIFICATION OR VESSEL TORTUOSITY. APPROACH WAS FROM THE RIGHT FEMORAL ARTERY. A BRITETIP SHEATH INTRODUCER (COMPLAINT PRODUCT) COULD NOT BE INSERTED IN THE PATIENT DUE TO THE FRICTION/RESISTANCE. ONLY A DILATOR WAS INSERTED, AND THEN THE BTSI WAS ATTEMPTED FOR INSERTION AGAIN BUT FAILED. WHEN THE USER CHECKED THE DEVICE, THE DISTAL SHEATH END WAS FOUND FRAYED. OTHER NEW PRODUCT (DETAILS UNKNOWN) WAS USED AND THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEMS. THERE WAS NO ADVERSE EVENT AND THE PATIENT IS IN STABLE CONDITION. THE PRODUCT WILL NOT BE RETURNED. THE PRODUCT WAS STORED, HANDLED, INSPECTED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE. NOTHING UNUSUAL WAS NOTED ABOUT THE DEVICE PRIOR TO USE. THERE WAS NO REPORT OF INJURY TO THE PATIENT. 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. REVIEW OF LOT 15272186 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. (B)(4). NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. NO NONCONFORMANCE RECORDS WERE ISSUED FOR THIS LOT. NO EXCURSIONS WERE FOUND FOR LOT 15272186. THE MOLDING CANNULA AND MOLDING CANNULA TIP PARAMETERS WERE REVIEWED AND NO ANOMALIES WERE FOUND. THE FPI /LPI MOLDING CANNULA RESULTS AND THE FPI / LPI MOLDING CANNULA TIP RESULTS WERE REVIEWED AND FOUND TO PASS. EXPIRATION DATES OF MATERIALS ASSIGNED TO THE MOLDED CANNULA WERE REVIEWED AND NO ANOMALIES WERE FOUND. THE RECEIVING INSPECTION RECORDS FOR THE USED POLYETHYLENE, H.D PART: 2951375 LOT: 201009030036, THE RECEIVING INSPECTION RECORDS FOR THE USED COLOR CON. WHITE PART: 2721201 LOT: 15222790 AND THE RECEIVING INSPECTION RECORDS FOR THE USED COEXTRUDED CANNULA FR7 PART: E7119501 LOT: 15235002 WERE REVIEWED, AND THESE LOTS WERE DEEMED ACCEPTABLE. WITH THE INFORMATION AVAILABLE AND WITHOUT THE PRODUCT AVAILABLE FOR ANALYSIS THE COMPLAINT COULD NOT BE CONFIRMED. INSPECTIONS ARE IN PLACE TO PREVENT DAMAGED PRODUCTS FROM LEAVING THE FACILITY AND THE DHR REVIEW CONFIRMED THAT THE PRODUCT MET SPECIFICATIONS. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. IT IS DIFFICULT TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT BASED ON THE LIMITED INFORMATION AVAILABLE.

    Description of Event or Problem · 1

    PTA WAS BEING PERFORMED ON A LESION IN THE LOWER LIMB WITH NO CALCIFICATION OR VESSEL TORTUOSITY AND THE RATE OF STENOSIS WAS 0%. APPROACH WAS FROM THE RIGHT FEMORAL ARTERY. A BRITETIP SHEATH INTRODUCER (COMPLAINT PRODUCT) COULD NOT BE INSERTED IN THE PATIENT DUE TO THE FRICTION/RESISTANCE. ONLY A DILATOR WAS INSERTED, AND THEN THE BTSI WAS ATTEMPTED FOR INSERTION AGAIN BUT FAILED. WHEN THE USER CHECKED THE DEVICE, THE DISTAL SHEATH END WAS FOUND FRAYED. OTHER NEW PRODUCT (DETAILS UNKNOWN) WAS USED AND THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEMS. THERE WAS NO ADVERSE EVENT AND THE PATIENT IS IN STABLE CONDITION. THE PRODUCT WILL NOT BE RETURNED. THE PRODUCT WAS STORED, HANDLED, INSPECTED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE. NOTHING UNUSUAL WAS NOTED ABOUT THE DEVICE PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SI BRITE TIP ENDOVASCULAR VASCULAR ACCESS (DYB) DYB CORDIS DE MEXICO NA 15272186

    Patients

    Seq Age Sex Outcome Treatment
    1