BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANTATA 2.9 SUPERSELECTIVE MICROCATHETER

    MDR report key: 6865503 · Received September 14, 2017

    Report

    Report Number
    1820334-2017-02904
    Event Type
    Malfunction
    Date Received
    September 14, 2017
    Date of Event
    July 28, 2017
    Report Date
    March 5, 2018
    Manufacturer
    COOK INC
    Product Code
    KRA
    UDI-DI
    10827002345826
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K) #: K131772. A REVIEW OF COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, SPECIFICATIONS, QUALITY CONTROL DATA AND VISUAL INSPECTION OF THE DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE PRODUCT WAS RETURNED. INVESTIGATION OF THE PRODUCT CONFIRMED THE PRESENCE OF FOREIGN MATTER IN THE SEALED PACKAGING. THE MANUFACTURING DOCUMENTS IN PLACE AT THE TIME OF MANUFACTURE WERE REVIEWED, AND IT WAS FOUND THAT THE PACKAGING WAS VISUALLY INSPECTED BY QUALITY CONTROL AND NO NOTABLE GAPS IN PRODUCTION OR PROCESSING CONTROLS WERE IDENTIFIED. THE RISK SPECIFICATION FOR THIS PRODUCT INCLUDES THE FAILURE MODE FOR PACKAGING NOT KEEPING THE DEVICE STERILE AND FOR NOT AND IDENTIFIES THAT MULTIPLE RISK CONTROLS ARE IN PLACE TO MITIGATE THE RISK OF THIS TYPE OF FAILURE. THE DEVICE HISTORY RECORD FOR LOT NUMBER 7773220 WAS REVIEWED. NO NON-CONFORMANCES WERE IDENTIFIED. A SEARCH OF OUR COMPLAINT RECORDS INDICATES THAT THIS IS THE ONLY COMPLAINT ON THE LOT NUMBER AT THE TIME OF INVESTIGATION. THE ROOT CAUSE OF THIS EVENT IS MANUFACTURING RELATED - FOREIGN MATTER AS EVIDENCED BY THE PHOTOS SENT BY THE CUSTOMER AND EXAMINATION OF THE RETURNED DEVICE. THE DEVICE IS OUT OF SPECIFICATION AS IT IS CONTAMINATED WITH FOREIGN MATTER. THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY AND EXAMINATION OF THE RETURNED DEVICE. WE HAVE NOTIFIED THE APPROPRIATE PERSONNEL AND WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED.

    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

    FOUND HAIR IN UNOPENED CANTATA PACKAGING. THE CUSTOMER REPORTED THAT, UPON INSPECTION OF THE CANTATA 2.9 SUPERSELECTIVE MICROCATHETER, A HAIR WAS DISCOVERED IN THE PACKAGING. THE DEVICE WAS NOT OPENED; ACCORDINGLY, NO PATIENT CONTACT WAS MADE, AND NO ADVERSE EVENTS OCCURRED. THE CUSTOMER DECLINED TO PROVIDE ADDITIONAL INFORMATION REGARDING THE INCIDENT. THE PRODUCT WAS RETURNED FOR EVALUATION, AND THE INVESTIGATION IS CURRENTLY PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644798 CANTATA 2.9 SUPERSELECTIVE MICROCATHETER KRA CATHETER, CONTINUOUS FLUSH KRA COOK INC N/A 10827002345826

    Patients

    Seq Age Sex Outcome Treatment
    1