BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISTA BRITE TIP GUIDING CATHETERS

    MDR report key: 2143194 · Received June 28, 2011

    Report

    Report Number
    9616099-2011-00453
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    May 20, 2011
    Report Date
    June 1, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQY
    PMA / PMN Number
    K021593
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF LOT 15351983 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. TWENTY SEVEN UNITS WERE REJECTED DURING THE FINAL ASSEMBLY OF THIS LOT. THE DHR REVIEW CONFIRMED THAT THE REJECTED UNITS WERE PROPERLY SEGREGATED AND DISCARDED. NO NONCONFORMANCE RECORDS WERE ISSUED FOR THIS LOT. NO EXCURSIONS WERE FOUND FOR LOT 15351983. 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. BASED ON THE DHR, THERE IS NO INDICATION OF A DESIGN OR MANUFACTURING RELATED ISSUE, THEREFORE, NO CORRECTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE 6F .070 3 DRC SH 100CM GUIDE HAD A "HOLE IN THE SIDE DUE TO A FOLD IN IT." THE PHYSICIAN INSERTED THE CATHETER AND NOTICED BLOOD FLOWING OUT THE GUIDE, NOTICING THAT THERE WAS A FOLD. THERE WAS NO PATIENT INJURY REPORTED AND NO ADDITIONAL DETAILS ARE AVAILABLE. THE PRODUCT WAS DISCARDED AND WILL NOT BE RETURNED.

    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 15351983

    Patients

    Seq Age Sex Outcome Treatment
    1