BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANTATA DUO 2.8 SUPERSELECTIVE MICROCATHETER

    MDR report key: 6643273 · Received June 15, 2017

    Report

    Report Number
    1820334-2017-01015
    Event Type
    Malfunction
    Date Received
    June 15, 2017
    Date of Event
    May 19, 2017
    Report Date
    January 25, 2018
    Manufacturer
    COOK INC
    Product Code
    KRA
    UDI-DI
    10827002238050
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: THE CANTATA DUO 2.8 SUPERSELECTIVE MICROCATHETER WAS PLACED INTO THE PATIENT'S LIVER. THE STRAIN RELIEF SEPARATED FROM THE HUB, NOT THE HUB FROM THE CATHETER. ADDITIONAL INFORMATION: PATIENT IDENTIFIER ADDED; 510(K) NUMBER = K101450 ADDED; ACTUAL DEVICE WAS NOT EVALUATED HOWEVER, THE DEVICE FROM SAME LOT WAS EVALUATED. INVESTIGATION - EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DRAWINGS, DEVICE HISTORY RECORD, DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), SPECIFICATIONS, AND QUALITY CONTROL WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS RADIOACTIVE DUE TO THE PROCEDURE AND COULD NOT BE RETURNED. HOWEVER, REPRESENTATIVE DEVICES FROM THE SAME LOT NUMBER WERE RETURNED BY THE REP. THE SAMPLES WERE EXAMINED FOR THE SECURITY OF THE RUBBER STRAIN RELIEF TO THE HUB. ALL SAMPLES SHOWED THE STRAIN RELIEF TO BE SECURELY POSITIONED ON THE HUB. THE STRAIN RELIEFS WERE PUSHED DOWN AND THE REPRESENTATIVE SAMPLES WERE ALSO EXAMINED UNDER MAGNIFICATION FOR THE PRESENCE OF GLUE ON THE HUB. THE SAMPLES EXHIBITED A CONSISTENT GLUE PATTERN ALONG THE EDGES OF HUB. A DOCUMENT-BASED INVESTIGATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE FINISHED PRODUCT WAS NOT MADE TO SPECIFICATIONS. NUMEROUS DESIGN VERIFICATION AND VALIDATION ACTIVITIES HAVE BEEN PERFORMED TO ENSURE THAT THIS DEVICE MEETS DESIGN REQUIREMENTS. REVIEW OF THE DEVICE HISTORY RECORD OF THE FINISHED PRODUCT SHOWS NO NONCONFORMING EVENTS THAT COULD CONTRIBUTE TO THIS FAILURE MODE. A COMPLAINT HISTORY SEARCH REVEALED THAT THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. THE MICROCATHETER DEVICES ARE RECEIVED AT COOK MEDICAL INC. FROM AN APPROVED VENDOR AND ARE 100% INSPECTED. ALL SAMPLES PASSED TENSILE TESTING CRITERIA. A STRAIN RELIEF IS USED TO IMPROVE OVERALL PERFORMANCE BY PROVIDING A TRANSITION FROM A FLEXIBLE CABLE TO A RIGID CONNECTOR OR CONNECTION POINT. THE STRAIN RELIEF RESISTS BENDING AND KINKING FORCES WHICH MAY BE APPLIED TO THE CATHETER. THE STRAIN RELIEF DOES NOT AID IN THE INJECTION OF MEDICATION. BASED ON THE INFORMATION PROVIDED, EXAMINATION OF THE RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION, A DEFINITE ROOT CAUSE COULD NOT BE DETERMINED; HOWEVER IT IS POSSIBLE THAT REPETITIVE HANDLING OF THE DEVICE MAY HAVE CONTRIBUTED TO THE STRAIN RELIEF GLUE BOND EXCEEDING TENSILE PARAMETERS. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. COOK MEDICAL HAS NOTIFIED THE APPROPRIATE PERSONNEL AND WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE FOR SIMILAR COMPLAINTS.

    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

    CUSTOMER REPORTED THAT A PATIENT UNDERWENT SUCCESSFUL PLACEMENT OF A CANTATA DUO 2.8 SUPERSELECTIVE MICROCATHETER FOR AN UNSPECIFIED INDICATION. THE RUBBER PART OF THE CATHETER SEPARATED FROM THE HUB AT THE TIME OF MEDICINAL INJECTION. THE CIRCUMSTANCES AND HANDLING CONDITIONS AT THE TIME OF FLUID INJECTION ARE NOT KNOWN. THE PHYSICIAN RECONNECTED THE RUBBER PART TO THE HUB AND PROCEEDED WITH UNEVENTFUL FLUID INJECTION. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424494 CANTATA DUO 2.8 SUPERSELECTIVE MICROCATHETER KRA CATHETER, CONTINUOUS FLUSH KRA COOK INC N/A 10827002238050

    Patients

    Seq Age Sex Outcome Treatment
    1