BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAKE REGION 0.027" PTFE GUIDEWIRE

    MDR report key: 24067204 · Received January 14, 2026

    Report

    Report Number
    1220648-2026-00701
    Event Type
    Injury
    Date Received
    January 14, 2026
    Date of Event
    January 3, 2026
    Report Date
    March 3, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    04260113630327
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4 UPDATED/CORRECTED WITH THE INVESTIGATED PRODUCT HAVING BEEN CHANGED. A150206 REMOVED FROM H6. INVESTIGATION SUMMARY: DIFFICULT TO ADVANCE: BASED ON THE CLINICAL DETAILS PROVIDED, THE DIFFICULTY TO ACCESS THE PA WAS A RESULT OF A NEW TRICUSPID CLIP THAT WAS PLACED. THEREFORE, THE CAUSE OF THE DIFFICULT TO ADVANCE WAS DETERMINED TO MOST LIKELY BE DUE TO PATIENT CONDITION. MAJOR BLEED: THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Additional Manufacturer Narrative · 0

    A4 IS UNKNOWN. THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER, THEREFORE, INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT IMPLANTED WITH AN IMPELLA RP FLEX EXPERIENCED LOSS OF FLOWS. THE PUMP WAS EXPLANTED AND THE PATIENT WAS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34290 LAKE REGION 0.027" PTFE GUIDEWIRE TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 8854003 04260113630327

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Required Intervention