BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANTATA 2.5 SUPERSELECTIVE MICROCATHETER

    MDR report key: 7552840 · Received May 30, 2018

    Report

    Report Number
    1820334-2018-01570
    Event Type
    Malfunction
    Date Received
    May 30, 2018
    Date of Event
    May 11, 2018
    Report Date
    November 15, 2018
    Manufacturer
    COOK INC
    Product Code
    KRA
    UDI-DI
    10827002545325
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D10 DEVICE AVAILABLE FOR EVALUATION? YES, PRODUCT RECEIVED ON: 20JUN2018. CORRECTED DATA: A3-GENDER:N/A. INVESTIGATION - EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, QUALITY CONTROL AND A VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. CLINICAL ASSESSMENT: AT THIS TIME, THE MOST PROBABLE CAUSE OF THIS EVENT IS MANUFACTURING RELATED. THE CUSTOMER RETURNED ONE MICROCATHETER SET IN AN UNOPENED CONDITION. NO DAMAGE WAS APPARENT ON THE PACKAGING. A VISUAL EXAMINATION CONFIRMED THE PRESENCE OF FOREIGN MATTER IN ONE OF THE PACKAGE SEALS. THE DEVICE WAS FOUND TO BE OUT OF SPECIFICATION FOR FOREIGN MATTER. ADDITIONALLY, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED FOR THIS DEVICE BY REVIEWING QUALITY CONTROL INSTRUCTIONS. QUALITY CONTROL INSPECTORS ARE INSTRUCTED TO EXAMINE THE ENTIRE PACKAGE FOR DEFECTS AND TO REJECT THE PACKAGE IF IT CONTAINS ANY VISIBLE CUTS, HOLES OR FOREIGN MATTER. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO RELEVANT NONCONFORMANCES FROM THIS LOT NUMBER. IT SHOULD BE NOTED THAT THERE WERE NO OTHER COMPLAINTS REPORTED FOR THIS LOT NUMBER. THERE WAS ONE COMPLAINT NOTED FROM A SIMILAR DEVICE LOT, HOWEVER THAT WAS FOR AN UNRELATED FAILURE MODE. BASED ON THE INFORMATION PROVIDED, THE EXAMINATION OF THE RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION, THE DEFINITIVE ROOT CAUSE WAS DETERMINED AS CAUSE TRACED TO MANUFACTURING.(QUALITY CONTROL DEFICIENCY). FOREIGN MATTER WAS PRESENT IN THE DEVICE PACKAGING AND IT SUBSEQUENTLY PASSED QUALITY CONTROL. THE APPLICABLE DEPARTMENT WAS CONTACTED AND INFORMED OF THIS COMPLAINT. RETRAINING WAS COMPLETED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510(K) #: K101450. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED A CANTATA 2.5 SUPERSELECTIVE MICROCATHETER WAS FOUND TO HAVE A FOREIGN BODY WITHIN THE SEALED STERILE PACKAGE. THIS DEFECT WAS IDENTIFIED AT THE DISTRIBUTION CENTER DURING QUALITY INSPECTION. AS REPORTED, THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397732 CANTATA 2.5 SUPERSELECTIVE MICROCATHETER KRA CATHETER, CONTINUOUS FLUSH KRA COOK INC 10827002545325

    Patients

    Seq Age Sex Outcome Treatment
    1