BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANTATA DUO 2.8 SUPERSELECTIVE MICROCATHETER

    MDR report key: 6792669 · Received August 14, 2017

    Report

    Report Number
    1820334-2017-02530
    Event Type
    Malfunction
    Date Received
    August 14, 2017
    Report Date
    April 4, 2018
    Manufacturer
    COOK INC
    Product Code
    KRA
    UDI-DI
    10827002238050
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K) #:K101450. INVESTIGATION ¿ EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, QUALITY CONTROL, SPECIFICATIONS, AND VISUAL INSPECTION OF THE DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE DEVICE (MCS-2.8-NT2-135-15-HP) LOT 7537122 WAS RETURNED IN SEALED, UNDAMAGED CONDITION. A VISUAL EXAMINATION NOTED A BLACK, FREE FLOATING SINGLE STRAND OF FOREIGN MATTER INSIDE THE STERILE PACKAGING. NO OTHER DEFECTS WERE NOTED IN THE PACKAGING. A THOROUGH REVIEW OF THE DEVICE HISTORY RECORD DID NOT OBSERVE ANY NON-CONFORMANCES THAT MAY HAVE CONTRIBUTED TO THIS INCIDENT ASSOCIATED WITH THE COMPLAINT LOT NUMBER; 7537122. ADDITIONALLY, A SEARCH OF THE MANUFACTURER'S DATABASE REVEALED THIS TO BE THE SECOND REPORTED COMPLAINT ASSOCIATED TO THE COMPLAINT LOT NUMBER 7537122. BECAUSE THE STERILE PACKAGING WAS SEALED, IT IS FEASIBLE TO SUGGEST THE FOREIGN MATTER WAS INTRODUCED DURING A MANUFACTURING PROCESS. FOREIGN MATTER SHOULD HAVE BEEN DETECTED DURING THE PACKAGING PROCESS AND/OR DURING POST STERILIZATION. THIS FAILURE MODE HAS BEEN ESCALATED PER INTERNAL PROCESSES. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. WE CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE PERSONNEL.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION. .

    Description of Event or Problem · 1

    FOREIGN MATERIAL WAS OBSERVED FREE-FLOATING WITHIN THE DEVICE PACKAGE. THE FOREIGN MATTER WAS OBSERVED DURING AN EVALUATION OF UNUSED SAMPLES RETURNED FOR A SEPARATE COMPLAINT INVESTIGATION. THERE WAS NO PATIENT CONTACT, ACCORDINGLY, NO ADVERSE PATIENT CONSEQUENCE. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573179 CANTATA DUO 2.8 SUPERSELECTIVE MICROCATHETER KRA CATHETER, CONTINUOUS FLUSH KRA COOK INC N/A 10827002238050

    Patients

    Seq Age Sex Outcome Treatment
    1