BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISTA BRITE TIP GUIDING CATHETERS

    MDR report key: 1822972 · Received September 1, 2010

    Report

    Report Number
    9616099-2010-00655
    Event Type
    Malfunction
    Date Received
    September 1, 2010
    Date of Event
    August 4, 2010
    Report Date
    August 6, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQY
    PMA / PMN Number
    K021593
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF TWO PRODUCTS USED IN THE SAME PATIENT AND REPORTED UNDER MANUFACTURING REPORT NUMBERS 9616099-2010-00654 AND 9616099-2010-00655. THE PRODUCT HAS BEEN RETURNED FOR EVALUATION, HOWEVER, THE ENGINEERING EVALUATION IS NOT YET COMPLETE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT REPORT STATED THAT A GOODMAN Y-CONNECTOR COULD NOT BE CONNECTED PROPERLY TO THE HUB OF A VISTA BRITE TIP GUIDE CATHETER; IT KEPT ROTATING AND BLOOD WAS ALSO OBSERVED LEAKING. THE VISTA BRITE TIP WAS EXCHANGED FOR ANOTHER VISTA BRITE TIP PRODUCT FROM A DIFFERENT LOT BUT THE SAME DIFFICULTY WAS EXPERIENCED. THE PHYSICIAN CONTINUED THE PROCEDURE AND IT WAS COMPLETED WITHOUT PATIENT INJURY. THE DEVICE WAS PREPPED FOLLOWING IFU INSTRUCTIONS. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT FOUND NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE DHR REVIEW CONFIRMED THAT THE REJECTED UNITS WERE PROPERLY SEGREGATED AND DISCARDED. 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 15150599. THE MOLDING MACHINE RESULTS WERE REVIEWED AND NO ANOMALIES WERE FOUND. THE COMPLAINT COULD NOT BE CONFIRMED WITHOUT A PRODUCT RETURN. IT IS NOT KNOWN IF SOME PROCEDURAL FACTORS OR USER HANDLING MAY HAVE CONTRIBUTED TO THIS EVENT. NO ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS ONE OF TWO PRODUCTS USED IN THE SAME PATIENT AND REPORTED UNDER MANUFACTURING REPORT NUMBERS 9616099-2010-00654 AND 9616099-2010-00655.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT WAS PERFORMED AND THE FOLLOWING WAS FOUND: REVIEW OF LOT 15150599 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 15150599. THE MOLDING MACHINE RESULTS WERE REVIEWED AND NO ANOMALIES WERE FOUND. CALIBRATION RECORDS FOR MOLDING MACHINE WERE REVIEWED, AND IT WAS FOUND THAT THE EQUIPMENT / TOOL WAS CALIBRATED IN A TIMELY MANNER. THE LOT INVOLVED IN THE COMPLAINT WAS MANUFACTURED WITHIN THE CALIBRATION DATES. PREVENTIVE MAINTENANCE RECORDS FOR MOLDING MACHINE WAS REVIEWED, AND IT WAS FOUND THAT THE PREVENTIVE MAINTENANCE WAS EXECUTED DURING THE ESTABLISHED TIME PERIOD. THE LOT INVOLVED IN THE COMPLAINT WAS MANUFACTURED WITHIN THE PREVENTIVE MAINTENANCE DATES. THIS IS ONE OF TWO PRODUCTS USED IN THE SAME PATIENT AND REPORTED UNDER MANUFACTURING REPORT NUMBERS 9616099-2010-00654 AND 9616099-2010-00655. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT.

    Description of Event or Problem · 1

    THE INFORMATION RECEIVED INDICATED THAT AN ATTEMPT WAS MADE TO CONNECT A GOODMAN Y-CONNECTOR TO THE HUB OF A BRITE TIP CATHETER, BUT IT COULD NOT BE CONNECTED PROPERLY AND KEPT ROTATING. BLOOD WAS ALSO OBSERVED LEAKING. THE BRITE TIP WAS CHANGED TO ANOTHER CORDIS VISTA BRITE TIP PRODUCT OF DIFFERENT LOT, BUT THE SAME DIFFICULTY WAS EXPERIENCED. THE PHYSICIAN CONTINUED THE PROCEDURE AND IT WAS COMPLETED WITHOUT PATIENT INJURY. THE PATIENT IS IN STABLE CONDITION. THE PATIENT WAS ADMITTED WITH AN 80% STENOSIS IN THE RENAL ARTERY. THE TARGET LESION HAD MILD CALCIFICATION AND VESSEL TORTUOSITY. THE DEVICE WAS PREPPED FOLLOWING IFU INSTRUCTIONS. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISTA BRITE TIP GUIDING CATHETERS CARDIOLOGY GUIDING CATHETERS (DQY) DQY CORDIS DE MEXICO NA 15150599

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR GOODMAN, (B)(4) Y-CONNECTOR.