BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDY OTW VASCULAR RETRIEVER

    MDR report key: 6202290 · Received December 23, 2016

    Report

    Report Number
    1820334-2016-01622
    Event Type
    Injury
    Date Received
    December 23, 2016
    Date of Event
    December 1, 2016
    Report Date
    August 23, 2017
    Manufacturer
    COOK INC
    Product Code
    MMX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION - EVALUATION. A REVIEW OF DOCUMENTATION, MANUFACTURING INSTRUCTIONS, DRAWINGS, INSTRUCTIONS FOR USE (IFU), AND QUALITY CONTROL DATA WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE NO PHYSICAL EXAMINATION COULD BE 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, NO PRODUCT 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 WARRANTED. MONITORING WILL CONTINUE TO BE PERFORMED FOR SIMILAR COMPLAINTS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING A THORACOABDOMINAL PROCEDURE ON AN IDE PATIENT, BECAUSE THE COOK BEACON TIP CATHETERS ARE ON RECALL A CATHETER FROM ANOTHER MANUFACTURER WAS USED. ALONG WITH AN INDY SNARE FROM COOK. THE SNARE CUT THE OTHER MANUFACTURER'S CATHETER IN HALF LEAVING THE REMAINING CATHETER IN THE BODY. THE SNARE THEN FAILED TO REMOVE AND BROKE OFF IN THE BODY. WHEN TRYING TO REMOVE THEM UP AND OVER WIRE FOR THE SNARE IT COMPLETELY CRUSHED THE DISTAL BODY COMPONENT. THEY WERE ABLE TO SALVAGE THE DISTAL COMPONENT AND RELINE ALL ITEMS TO SMASH THE CATHETER AND SNARE PIECES BETWEEN GRAFTS. THE PATIENT OUTCOME WAS GOOD BUT THE INITIAL REPORTER FEELS THIS WAS AN UNNECESSARY PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852608 INDY OTW VASCULAR RETRIEVER MMX DEVICE, PERCUTANEOUS RETRIEVAL MMX COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention