BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFORMER INTRODUCER

    MDR report key: 6950464 · Received October 14, 2017

    Report

    Report Number
    1820334-2017-03534
    Event Type
    Malfunction
    Date Received
    October 14, 2017
    Date of Event
    October 2, 2017
    Report Date
    January 8, 2018
    Manufacturer
    COOK VASCULAR INC
    Product Code
    DYB
    UDI-DI
    00827002105386
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE PROVIDED UPON CONCLUSION.

    Additional Manufacturer Narrative · 1

    INVESTIGATION - EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), AND QUALITY CONTROL WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICES WERE NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATION COULD BE PERFORMED. HOWEVER, A DOCUMENT-BASED INVESTIGATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE FINISHED PRODUCTS WERE NOT MADE TO SPECIFICATIONS. REVIEW OF THE DEVICE HISTORY RECORD OF THE FINISHED PRODUCTS SHOWS NO NON-CONFORMANCES. IT SHOULD ALSO BE NOTED, THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. BASED ON THE INFORMATION PROVIDED, NO PRODUCTS RETURNED, AND THE RESULTS OF OUR INVESTIGATION; A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND MONITORING WILL CONTINUE TO BE PERFORMED FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    TWO PERFORMER INTRODUCERS WERE USED IN AN ENDOVASCULAR PROCEDURE. IT WAS REPORTED THAT, 700CC OF BLOOD WAS LEAKING THROUGH THE VALVE OF THE INTRODUCERS DURING THE PROCEDURE. NO ADDITIONAL TREATMENT WAS REQUIRED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY . A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. 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
    729921 PERFORMER INTRODUCER DYB INTRODUCER, CATHETER DYB COOK VASCULAR INC N/A 00827002105386

    Patients

    Seq Age Sex Outcome Treatment
    1 Other