BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA CP

    MDR report key: 23521520 · Received November 11, 2025

    Report

    Report Number
    1220648-2025-48258
    Event Type
    Malfunction
    Date Received
    November 11, 2025
    Date of Event
    October 21, 2025
    Report Date
    January 6, 2026
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    04260113630280
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: UNABLE TO PLACE OR POSITION: IMPELLA CP SN (B)(6), TWO 14 FR X 25 CM INTRODUCERS, AND A PURGE CASSETTE WERE RETURNED FOR INVESTIGATION. ONE INTRODUCER WAS IN A PEEL-AWAY STATE AND HAD SEVERAL KINKS ALONG ITS LENGTH, BUT NO TIP DAMAGE. THE SECOND INTRODUCER ALSO HAD SEVERAL KINKS, WITH KINKED TIP. NO DAMAGE WAS FOUND ON THE RETURNED PUMP OR PURGE CASSETTE. THE PUMP CANNULA WAS ALSO KINKED LENGTHWISE ON THE RETURNED PRODUCT. NO OTHER PHYSICAL DAMAGE WAS NOTED ON THE RETURNED PUMP. THE PUMP WAS TESTED IN A BUCKET OF WATER AND NO ABNORMALITIES WERE OBSERVED. THE CAUSE OF THE DELIVERY ISSUE WAS RELATED TO KINKS ON THE INTRODUCER AND THE PUMP¿S CANNULA. DEVICE HISTORY LOT DEVICE BATCH: 1955208. DEVICE HISTORY BATCH SUBCOMPONENT LOT: NA. DEVICE HISTORY REVIEW THE PUMP SN (B)(6) PASSED ALL POST STERILE INSPECTION CHECKS.

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS RETURNED, AND AN EVALUATION IS UNDERWAY. UPON COMPLETION OF OUR ANALYSIS, A SUPPLEMENTAL REPORT WILL BE FILED. D9 UPDATED.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT DURING THE IMPELLA CP IMPLANTATION, IT WAS DIFFICULT TO PLACE THE PEEL-AWAY-SHEATH. AFTER THAT CORRECT POSITION WAS NOTED ACCORDING TO FLUOROSCOPY AND CONTRAST AGENT ADMINISTRATION. WHEN PLACING THE IMPELLA, THE PUMP COULD NOT BE FULLY PLACED. IT GOT STUCK IN THE SHEATH AND COULD NOT BE ADVANCED ANY FURTHER. A KINK IN THE SHEATH WAS NOW VISIBLE IN FLUOROSCOPY. REMOVAL OF THE PUMP WAS ONLY POSSIBLE BY PEELING THE SHEATH. A NEW PUMP WAS IMPLANTED WITH NEW PEEL-AWAY-SHEATH. THERE WAS NO HARM TO THE PATIENT. THERE ARE TWO RELATED REPORTS. THIS REPORT REPRESENTS THE PUMP AND ANOTHER REPORT WAS SUBMITTED TO REPRESENT THE INTRODUCER. REFER TO SECTION H10 FOR THE RELATED REPORT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2436064 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2026718295 04260113630280

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male