BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRODUCER, CATHETER (INTRODUCER)

    MDR report key: 25127404 · Received May 8, 2026

    Report

    Report Number
    1220648-2026-07697
    Event Type
    Injury
    Date Received
    May 8, 2026
    Date of Event
    May 2, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    DYB
    UDI-DI
    00813502011678
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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. INVESTIGATION SUMMARY PATIENT-DEVICE INTERACTION/PERIPHERAL ARTERIAL ISCHEMIA: THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Additional Manufacturer Narrative · 0

    THIS IS ONE OF TWO RELATED REPORTS. THIS REPORT REPRESENTS THE INTRODUCER AND ANOTHER REPORT WAS SUBMITTED TO REPRESENT THE IMPELLA CP. 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

    CLINICAL NARRATIVE: AN IMPELLA CP WAS INSERTED VIA THE 14FR INTRODUCER IN THE FEMORAL ARTERY TO SUPPORT THE 40 YEAR OLD MALE PATIENT WHO HAD BEEN ADMITTED IN WITH INDICATION OF ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK, PRESENTING IN SCAI STAGE E SHOCK. THE UNDERLYING MEDICAL HISTORY WAS NOT SHARED. WHILE ON THE CP SUPPORT THE TEAM ADDED VA-EXTRA CORPOREAL MEMBRANE OXYGENATION (ECMO). WHILE THE CANNULATION OF THE ECMO WAS ONGOING THE TEAM MADE THE DECISION TO PLACE DISTAL PERFUSION TO BOTH THE ECMO AND CP ACCESSED LIMBS. THE 14FR PEEL AWAY SHEATH WAS LEFT IN DURING INSERTION AND THE PATIENT HAD MINIMAL PERIPHERAL PULSES ON ALL FOUR EXTREMITIES. THE CONSOLE DID ALARM FOR AN "IN AORTA" ALARM DURING THE SUPPORT. THE PUMP WAS EXHIBITING THE POSITIONAL AND PLACEMENT UNKNOWN ALARMS. THE TEAM MADE DECISION TO EXPLANT THE PUMP AT THE SECOND MEDICAL CENTER THEY TRANSPORTED THE PATIENT TO FOR A HIGHER LEVEL OF CARE AT THE TERTIARY MEDICAL CENTER. PATIENT OUTCOME IS NOT KNOWN AT THIS TIME. LIMB ISCHEMIA MAY BE INFLUENCED BY PATIENT-SPECIFIC FACTORS SUCH AS SEVERE PERIPHERAL VASCULAR DISEASE, UNDERLYING CRITICAL ILLNESS, HEMODYNAMIC INSTABILITY, AND VASCULAR ACCESS CHARACTERISTICS.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO IMAGING PERFORMED AT THE TIME OF THE ALARM. THE ACCOUNT DID NOT REACH OUT WHILE PREPARING TO TRANSPORT THE PATIENT; INSTEAD, A CALL WAS RECEIVED FROM CSC. THE PATIENT WAS ON ECMO AND WAS NOT REPOSITIONED PRIOR TO THE ALARM. THERE WERE NO CONCERNS WITH THE IMPELLA DESPITE THE ALARMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66815 INTRODUCER, CATHETER (INTRODUCER) DYB ABIOMED, INC. - 1220648 S10020644 00813502011678

    Patients

    Seq Age Sex Outcome Treatment
    1