BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDY OTW VASCULAR RETRIEVER

    MDR report key: 8016189 · Received October 29, 2018

    Report

    Report Number
    1820334-2018-03078
    Event Type
    Malfunction
    Date Received
    October 29, 2018
    Date of Event
    October 4, 2018
    Report Date
    January 8, 2019
    Manufacturer
    COOK INC
    Product Code
    MMX
    UDI-DI
    00827002518360
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: CONCOMITANT MEDICAL PRODUCTS. INVESTIGATION: EVALUATION: A VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED. A DOCUMENT BASED INVESTIGATION WAS ALSO PERFORMED INCLUDING A REVIEW OF THE DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE, QUALITY CONTROL DATA, AND SPECIFICATIONS. THE INDY-8.0-35-100-40 WAS RETURNED STILL SEALED WITHIN THE PACKAGING. THERE WERE NO DAMAGES TO THE PACKAGE OBSERVED. TWO PIECES OF WHITE FOREIGN MATTER WERE IDENTIFIED SEALED WITHIN THE BOTTOM LEFT SECTION OF THE PACKAGE. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THE COMPLAINT DEVICE LOT NUMBER: 9073860. A COMPLAINT HISTORY SEARCH REVEALED THIS TO BE THE ONLY REPORTED COMPLAINT ASSOCIATED TO THE COMPLAINT LOT NUMBER: 9073860. THE DEVICE IS SHIPPED WITH OUR PRODUCT IFU WHICH CONTAINS WARNINGS, PRECAUTIONS AND INSTRUCTIONS FOR USE. THE IFU STATES, ¿DO NOT USE THE PRODUCT IF THERE IS DOUBT AS TO WHETHER THE PRODUCT IS STERILE.¿ THE CAUSE FOR THIS INCIDENT HAS BEEN TRACED TO MANUFACTURING; A QUALITY CONTROL DEFICIENCY. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER RISK MITIGATING ACTIVITY IS REQUIRED. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED AND WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR 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

    THERE HAS BEEN NO NEW INFORMATION RECEIVED SINCE THE LAST REPORT WAS SUBMITTED.

    Additional Manufacturer Narrative · 1

    PMA/510(K): K160593. 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

    IT WAS REPORTED THE CUSTOMER FOUND A PIECE OF PLASTIC-LIKE FOREIGN MATTER INSIDE THE UNOPENED PACKAGE. THE PACKAGE WAS NOT OPENED. NO ADVERSE EFFECTS TO A PATIENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856074 INDY OTW VASCULAR RETRIEVER MMX DEVICE, PERCUTANEOUS RETRIEVAL MMX COOK INC G51836 9073860 00827002518360

    Patients

    Seq Age Sex Outcome Treatment
    1