BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFORMER INTRODUCER

    MDR report key: 6151372 · Received December 7, 2016

    Report

    Report Number
    1820334-2016-01425
    Event Type
    Malfunction
    Date Received
    December 7, 2016
    Report Date
    October 22, 2019
    Manufacturer
    COOK INC
    Product Code
    DYB
    UDI-DI
    00827002134959
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    CORRECTION: THIS REPORT IS A RESUBMISSION OF THE REPORT PREVIOUSLY SUBMITTED ON (12 JAN 2017) WITH THE INCORRECT MDR NUMBER. CORRECTED INFORMATION: (B)(4). INVESTIGATION - EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DRAWINGS, DEVICE HISTORY RECORD, DOCUMENTATION, MANUFACTURING INSTRUCTIONS AND QUALITY CONTROL OF THE DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED; HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. NO IMAGES WERE AVAILABLE AND A REVIEW OF THE PRODUCT WAS NOT PERFORMED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO NON-CONFORMANCES WERE NOTED. A SEARCH REVEALED THIS COMPLAINT TO BE THE ONLY REPORTED COMPLAINT ASSOCIATED TO THE COMPLAINT LOT NUMBER 6810191. ALTHOUGH THE DEVICES WERE NOT RETURNED FOR EVALUATION, THE ROOT CAUSE WAS DETERMINED TO BE MANUFACTURING RELATED. MEASURES HAVE BEEN PREVIOUSLY INITIATED TO ADDRESS THIS ISSUE. A QUALITY ENGINEERING RISK ASSESSMENT HAS DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS IT CONCLUDED THAT ITS OCCURRENCE IS UNLIKELY TO LEAD TO A SERIOUS HEALTH CONSEQUENCE TO THE PATIENT. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PERFORMER INTRODUCER VALVE WAS LEAKING DURING THE PROCEDURE. THE DEVICE WAS EXCHANGED DURING THE PROCEDURE WITH A DEVICE THAT WORKS PROPERLY. THE PATIENT DID NOT REQUIRE ADDITIONAL PROCEDURES NOR EXPERIENCE ADVERSE CONSEQUENCES.

    Description of Event or Problem · 1

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803082 PERFORMER INTRODUCER DYB INTRODUCER, CATHETER DYB COOK INC N/A 00827002134959

    Patients

    Seq Age Sex Outcome Treatment
    1