BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER

    MDR report key: 6936505 · Received October 10, 2017

    Report

    Report Number
    1820334-2017-03466
    Event Type
    Injury
    Date Received
    October 10, 2017
    Date of Event
    September 28, 2017
    Report Date
    January 24, 2018
    Manufacturer
    COOK INC
    Product Code
    DQO
    Removal / Correction Number
    Z-2610-2016
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. INVESTIGATION - EVALUATION A REVIEW OF THE COMPLAINT HISTORY, DIMENSIONAL VERIFICATION, QUALITY CONTROL, AND VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. ONE USED BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER WAS RETURNED FOR INVESTIGATION. THE DISTAL TIP IS SEPARATED. THE DISTAL SECTION IS FRAYED AT THE SEPARATION SITE. A COMPRESSION IS NOTED AT 1.4 CM FROM THE PROXIMAL END OF THE DISTAL SEPARATED SECTION. THE COMPLAINANT DEVICE LOT NUMBER IS UNKNOWN. THUS, A REVIEW OF THE DEVICE HISTORY RECORD, NONCONFORMANCE HISTORY, AND RELATED PRODUCT COMPLAINTS QUERY COULD NOT BE CONDUCTED. BASED ON THE INFORMATION PROVIDED, EXAMINATION OF THE RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION; A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED; HOWEVER, PROCESSING AND ENVIRONMENTAL FACTORS HAVE BEEN ATTRIBUTED TO THIS FAILURE. APPROPRIATE MEASURES HAVE BEEN INITIATED TO ADDRESS THIS FAILURE MODE. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND MONITORING WILL CONTINUE TO BE PERFORMED FOR SIMILAR COMPLAINTS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: PMA/510(K) # K133130; (B)(4); RECALL: Z-2610-2016. IT HAS BEEN CONFIRMED THAT THE NOTIFICATION OF THE PRODUCT RECALL WAS DELIVERED TO THIS FACILITY ON (B)(6) 2016. A RESPONSE FROM THAT SPECIFIC VA FACILITY WAS NOT RECEIVED. HOWEVER, THEY WERE CONTACTED ON FIVE SEPARATE OCCASIONS FOR THE EFFECTIVENESS CHECK AS A NON-RESPONDER. THE EVENT IS CURRENTLY UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE PROVIDED UPON CONCLUSION.

    Description of Event or Problem · 1

    A BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER WAS USED IN AN UNSPECIFIED PROCEDURE. IT WAS REPORTED THAT, THE TIP SEPARATED WHILE INSIDE THE PATIENT. THEY WERE ABLE TO RETRIEVE THE TIP DURING THE SAME PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. HOWEVER, ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714379 BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention