BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDY OTW VASCULAR RETRIEVER

    MDR report key: 6427465 · Received March 23, 2017

    Report

    Report Number
    1820334-2017-00441
    Event Type
    Injury
    Date Received
    March 23, 2017
    Date of Event
    February 21, 2017
    Report Date
    August 17, 2017
    Manufacturer
    COOK INC
    Product Code
    MMX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510(K) # : K160593. THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED (31JUL2017) STATING THAT THE BASKET WAS NOT RETRIEVED AS THE PATIENT DIED TWO DAYS AFTER IMPLANTATION. THE DEATH WAS NOT RELATED TO THE DEVICE MALFUNCTION/IMPLANTATION. A REVIEW OF THE INSTRUCTIONS FOR USE (IFU) AND QUALITY CONTROL DATA 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. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; ACCORDINGLY A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. BASED ON THE INFORMATION PROVIDED AND RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. MEASURES HAVE BEEN INITIATED TO ADDRESS THIS FAILURE MODE. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. MONITORING FOR SIMILAR COMPLAINTS WILL CONTINUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON AN UNSPECIFIED DATE, THE PATIENT UNDERWENT A COMBINED PROCEDURE, THORACIC WITH TBRANCH UNIBODY ZBIS AND LEGS WHILE USING AN INDY OTW VASCULAR RETRIEVER. THE ZBIS WAS INSERTED AND THE WIRE CACHED WITH AN INDY SNARE. WHEN ATTEMPTING TO PULL BACK THE SNARE WITH THE CACHED WIRE, THE SNARE'S BASKET BROKE. THE DEVICE REMAINS IN THE PATIENT'S BODY AS IT WAS NOT RETRIEVABLE. THE PATIENT'S CONDITION WAS NOT PROVIDED. THE DEVICE WILL NOT BE AVAILABLE FOR INVESTIGATION AS A NURSE THREW OUT THE PACKAGE AND THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210959 INDY OTW VASCULAR RETRIEVER MMX DEVICE, PERCUTANEOUS RETRIEVAL MMX COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention