BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDE WIRE 0.018"PTFE COATED

    MDR report key: 24500573 · Received March 3, 2026

    Report

    Report Number
    1220648-2026-04432
    Event Type
    Malfunction
    Date Received
    March 3, 2026
    Date of Event
    December 22, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: UPDATED CODES BASED ON THE RESULTS OF THE INVESTIGATION. H11: UPDATED BASED ON THE RESULTS OF THE INVESTIGATION. THE CAUSE OF THE DIFFICULT TO ADVANCE WAS DETERMINED TO BE PATIENT CONDITION AS THE PATIENT HAD SEVERE STENOSIS PREVENTING SUCCESSFUL DELIVERY OF IMPELLA.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ABIOMED INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ABIOMED INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    AN 80-YEAR-OLD FEMALE PATIENT WITH PRIOR CORONARY ARTERY BYPASS GRAFT, DIABETES AND RENAL INSUFFICIENCY WAS TREATED WITH AN IMPELLA 5.5 DUE TO HIGH-RISK SURGERY INDICATION. PATIENT DEVELOPED A POST-CARDIOTOMY CARDIOGENIC SHOCK AND LOW CARDIAC OUTPUT SYNDROME POST SURGERY. ACCESS FOR THE PUMP WAS ACHIEVED VIA DIRECT AORTIC APPROACH. ONCE GRAFT WAS PLACED AND SHEATH PLACED, HCP WAS UNABLE TO SUCCESSFULLY PASS AN .035 J-WIRE THROUGH THE AORTIC VALVE. SEVERAL ATTEMPTS WERE MADE WITH J-WIRE, PIGTAIL CATHETER, AND ABIOMED .018 WIRE, BUT WERE UNSUCCESSFUL. ANOTHER HCP WAS ABLE TO PASS WIRE THROUGH AORTIC VALVE AND PLACE PUMP SUCCESSFULLY. ONE DAY AFTER PUMP INSERTION AROUND SUPRASTERNAL EXIT SITE, OOZING WAS NOTED AND PATIENT RECEIVED ONE UNIT OF PACKED RED BLOOD CELLS. PATIENT REQUIRING CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) AND EXTRACORPOREAL LIFE SUPPORT. PATIENT WAS UNABLE TO BE WOKEN UP FROM ANESTHESIA. CT SHOWED A RIGHT-SIDED STROKE AND FAMILY OF PATIENT DECIDED TO WITHDRAW CARE. THE USE OF MULTIPLE MECHANICAL CIRCULATORY SUPPORT SYSTEMS, SUCH AS COMBINED IMPELLA AND EXTRACORPOREAL CIRCULATORY LIFE SUPPORT (ECLS) THERAPY, IS ASSOCIATED WITH AN INCREASED RISK OF ADVERSE EVENTS DUE TO THE CUMULATIVE COMPLEXITY OF THE SUPPORT STRATEGY AND THE ADDITIVE DEVICE-RELATED RISKS. RENAL FAILURE NOT CODED TO DEVICE AS THIS WAS A PRE-EXISTING CONDITION OF THE PATIENT BEFORE TREATMENT. DEATH WAS CONSERVATIVELY CODED AS MOST LIKELY DUE TO UNDERLYING DISEASE AND NOT DEVICE-RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554572 GUIDE WIRE 0.018"PTFE COATED TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 9464321

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female