BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA RP PUMP

    MDR report key: 9675778 · Received February 6, 2020

    Report

    Report Number
    1220648-2020-00334
    Event Type
    Malfunction
    Date Received
    February 6, 2020
    Date of Event
    January 12, 2020
    Report Date
    March 24, 2020
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    813502011029
    PMA / PMN Number
    P170011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED G4 PMA/510(K) NUMBER FROM P140003 TO P170011. THE WIRE USED TO INSERT THE REPLACEMENT RP IN THE LFV WAS SLIGHTLY LARGER AT .032" VS THE NORMAL .027" DIAMETER WIRE USED FOR RP. THE TEAM WAS SAID TO HAVE DIFFICULTY PLACING THE WIRE, BUT NOT THE INTRODUCER. ONLY DATA FROM THE ATTEMPTED RESTARTS AFTER THE PUMP STOP WAS RETURNED. THE RETURNED PUMP CONFIRMED THE BREAK AT THE MOTOR HOUSING, AND THE OUTFLOW CAGE WAS SHOWN TO HAVE BEEN BENT IN ONE DIRECTION. A RETURNED IMAGE FROM THE FIELD SHOWS THE SEVERED PUMP WITH THE BENT CAGE INSIDE THE PATIENT, INDICATING POSSIBLE PLACEMENT DIFFICULTY. WITHOUT FURTHER CLINICAL INFORMATION AND COMPLETE LOGS, THE ROOT CAUSE OF THE PUMP DAMAGE WAS UNABLE TO BE DEFINITIVELY DETERMINED.

    Additional Manufacturer Narrative · 1

    THE IMPELLA RP WAS RETURNED BY THE CUSTOMER AND A FAILURE ANALYSIS INVESTIGATION IS UNDERWAY. A SUPPLEMENTAL MDR WILL BE FILED AT THE COMPLETION OF THE DEVICE'S INVESTIGATION.

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED A (B)(6) WHITE MALE PATIENT HAD IMPELLA RP PUMP INSERTED. THE PHYSICIAN WAS REMOVING THE RP PUMP AND UPON REMOVAL THE CATHETER HAD FRACTURED FROM THE MOTOR HOUSING. ONLY THE CATHETER WAS REMOVED. X-RAY CONFIRMED THAT THE RP MOTOR HOUSING WAS RIGHT AT THE LEFT ILIAC. THE PUMP REMNANTS WERE REMOVED THROUGH MULTIPLE MEANS INCLUDING SNARING AND FORCEPS FOLLOWED BY CUT DOWN. PLASTIC COATING WAS NOTED TO BE CHIPPED OFF BY FORCEPS, BUT IT WAS ABLE TO BE EXTRACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140404 IMPELLA RP PUMP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP, OZD ABIOMED, INC. IMPELLA RP US PUMP SET 1437014 813502011029

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention