BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT, 14FR INTRODUCER, 13CM&25CM, STERILE

    MDR report key: 24698375 · Received March 26, 2026

    Report

    Report Number
    1220648-2026-05961
    Event Type
    Malfunction
    Date Received
    March 26, 2026
    Date of Event
    March 18, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    DYB
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION: TYPE, FINDINGS, CONCLUSION CODES AND H6 COMPONENT CODES WERE UPDATED ACCORDINGLY BASED ON THE COMPLETED INVESTIGATION. THE DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION/ANALYSIS OF THE DEVICE WAS NOT POSSIBLE. THE CAUSE OF PRODUCT DAMAGE WAS MOST LIKELY USE ISSUE RELATED SINCE EXCESSIVE FORCE WAS APPLIED AND IMPELLA CP WAS PULLED INTO THE PEEL-AWAY SHEATH WITH COMPANION SHEATH STILL IN PLACE.

    Description of Event or Problem · 0

    CLINICAL NARRATIVE: THE IMPELLA CP WAS INSERTED VIA THE 14FR X13CM INTRODUCER AT THE FEMORAL ARTERY TO SUPPORT THE 73-YEAR-OLD FEMALE ADMITTED IN WITH KNOWN CORONARY ARTERY DISEASE AND HAVING A PROTECTED PERCUTANEOUS CORONARY INTERVENTION (PCI). NO OTHER MEDICAL HISTORY WAS SHARED. UPON COMPLETION OF THE PCI THE PHYSICIAN PULLED THE IMPELLA AND FOUND THE PUMP TO BECOME STUCK IN THE 14FR WHILE BOTH THE 7FR COMPANION SHEATH AND IMPELLA WERE RETAINED WITHIN IT. THE TEAM REMOVED ALL SHEATHS AND THE PUMP AS ONE SYSTEM AND ACHIEVED HEMOSTASIS WITH PERCLOSE AS PLANNED. THERE WAS NO HARM TO THE PATIENT. UPON REVIEW THE TEAM DID OBSERVE THE 14FR TO HAVE A SPLIT/TEAR DAMAGE, NOT LOCATED AT THE TIP OF THE SHEATH. THERE WAS NO CONSEQUENCE TO THE PATIENT AND SUPPORT WHICH HAD ALREADY BEEN TERMINATED AS THE PCI WAS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275521 KIT, 14FR INTRODUCER, 13CM&25CM, STERILE INTRODUCER, CATHETER (INTRODUCER) DYB ABIOMED, INC. - 1220648 S9834193

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female