BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFORMER INTRODUCER

    MDR report key: 4102620 · Received September 11, 2014

    Report

    Report Number
    1820334-2014-00419
    Event Type
    Injury
    Date Received
    September 11, 2014
    Date of Event
    August 11, 2014
    Report Date
    August 12, 2014
    Manufacturer
    COOK, INC.
    Product Code
    DYB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS (MI), QUALITY CONTROL (QC) AND SPECIFICATIONS WAS CONDUCTED DURING THE INVESTIGATION. THIS DEVICE IS 100% QUALITY CONTROL INSPECTED TO CONFIRM THE FLARE OF THE SHEATH IS CAUGHT SECURELY IN THE CHECK-FLO ASSEMBLY AND THAT THE SHEATH DOES NOT ROTATE IN FITTINGS. AN INSTRUCTIONS FOR USE (IFU) IS PROVIDED THAT INCLUDES THE FOLLOWING PRECAUTION. "ALL INSTRUMENTS OR CATHETERS USED WITH THIS PRODUCT SHOULD MOVE FREELY THROUGH THE VALVE AND SHEATH. DAMAGE TO THE VALVE/INTRODUCER MAY RESULT WHEN THE FIT IS TIGHT." WITHOUT BENEFIT OF INSPECTING THE COMPLAINT DEVICE, IT IS DIFFICULT TO DETERMINE WITH CERTAINTY WHY THE FAILURE MODE OCCURRED. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED OF THIS EVENT AND WE WILL CONTINUE TO MONITOR COMPLAINTS FOR THIS FAILURE MODE. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    PT INFO UNKNOWN, AS NOT PROVIDED BY THE REPORTER. LOT NUMBER HAS NOT BEEN PROVIDED BY THE REPORTER. EXPIRATION DATE UNKNOWN AS LOT IS UNKNOWN. (B)(4). EVENT EVALUATION: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    WHEN THE IMPELLA WAS REMOVED AND REINSERTED, THE PHYSICIAN MET RESISTANCE AND THE HUB BROKE OFF OF THE SHEATH. THE PATIENT HAD TO RECEIVE BLOOD. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. PER 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
    562960 PERFORMER INTRODUCER DYB INTRODUCER CATHETER DYB COOK, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention