BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANTATA 2.5 SUPERSELECTIVE MICROCATHETER

    MDR report key: 6751014 · Received July 28, 2017

    Report

    Report Number
    1820334-2017-02171
    Event Type
    Injury
    Date Received
    July 28, 2017
    Date of Event
    July 14, 2017
    Report Date
    November 10, 2017
    Manufacturer
    COOK INC
    Product Code
    KRA
    UDI-DI
    10827002545318
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/ 510(K): K101450. INVESTIGATION - EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DRAWINGS, DIMENSIONAL VERIFICATION, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL, AND VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE DEVICE WAS RETURNED USED. IT WAS CONFIRMED THAT THE CATHETER HAD TORN. THE INNER AND OUTER DIAMETERS OF THE CATHETER WERE MEASURED AND PERFORMED WITHIN MANUFACTURING SPECIFICATION. THERE WAS EXCESSIVE WINDING WHICH MAY HAVE BEEN DUE TO EXCESSIVE TUGGING. THERE IS NO EVIDENCE TO SUGGEST THE FINISHED PRODUCT WAS NOT MADE TO SPECIFICATIONS. REVIEW OF THE DEVICE HISTORY RECORD OF THE FINISHED PRODUCT SHOWS NO NONCONFORMING EVENTS THAT WOULD CONTRIBUTE TO THE REPORTED FAILURE MODE. THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF OUR INVESTIGATION; A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. PER THE RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. MONITORING WILL CONTINUE TO BE PERFORMED FOR SIMILAR COMPLAINTS. 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.

    Additional Manufacturer Narrative · 1

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. (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

    INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT WAS DIAGNOSED BY CT ( COMPUTED TOMOGRAPHY) SCAN WITH AN ABDOMINAL BLEED. THE ETIOLOGY OF THE BLEED WAS NOT IDENTIFIED. THE PATIENT WAS UNDERGOING A PROCEDURE TO LOCATE AND EMBOLIZE THE SOURCE OF THE BLEED. THE PHYSICIAN ATTEMPTED TO LOCATE THE SOURCE OF THE BLEED BY PROBING THE TRUNCUS WITH A COMPETITOR PRODUCT AND PROBING THE LEFT GASTRIC ARTERY WITH A CANTATA DUO 2.5 SUPERSELECTIVE MICROCATHETER. THE PHYSICIAN PULLED THE CANTATA DUO 2.5 SUPERSELECTIVE MICROCATHETER IN ORDER TO PROBE THE AMS WITH THE COMPETITOR PRODUCT. A PORTION OF THE MICROCATHETER REMAINED WITHIN THE AORTA AT THE TIP OF THE COMPETITOR PRODUCT WHILE ATTEMPTING TO REMOVE THE DEVICE. THE BROKEN PORTION WAS RETRIEVED USING A SLING DEVICE AND REMOVED THROUGH A SECOND 4 FR CATHETER. THE DEVICE IS AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532388 CANTATA 2.5 SUPERSELECTIVE MICROCATHETER KRA CATHETER, CONTINUOUS FLUSH KRA COOK INC N/A 10827002545318

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention UNSPECIFIED COBRA CATHETER.