BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHEATH, 7FR SINGLE ACCESS SHEATH

    MDR report key: 24766991 · Received April 2, 2026

    Report

    Report Number
    1220648-2026-06314
    Event Type
    Injury
    Date Received
    April 2, 2026
    Date of Event
    March 26, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    DYB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS DISCARDED. 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

    UPDATED INFORMATION: D3 MFR FAX NUMBER ADDED. D4 CATALOG, UDI, LOT, AND EXP DATE UPDATED. H4 DEVICE MFR DATE UPDATED.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS INITIALLY MISIDENTIFIED AS THE INTRODUCER; THE CORRECT DEVICE IS THE COMPANION SHEATH, AS REFLECTED IN D1 (BRAND NAME) AND D4 (CATALOG NUMBER). OTHER PRODUCT-SPECIFIC INFORMATION (E.G., UNIQUE DEVICE IDENTIFIER, LOT/SERIAL NUMBER, EXPIRATION DATE, AND DATE OF MANUFACTURE) IS UNKNOWN AT THE TIME OF THIS MDR SUBMISSION. SHOULD THIS OR ANY OTHER RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 0

    CLINICAL NARRATIVE: AN IMPELLA CP WAS INSERTED VIA THE FEMORAL ARTERY TO SUPPORT THE 78 YEAR OLD MALE PATIENT WHO HAD BEEN ADMITTED IN WITH KNOWN CORONARY ARTERY DISEASE WITH A PLANNED PROTECTED PERCUTANEOUS CORONARY INTERVENTION (PCI). OTHER MEDICAL HISTORY WAS NOT SHARED. THE PUMP WAS PLACED VIA THE 14FR SHEATH USING THE SINGLE ACCESS TECHNIQUE AND USE OF THE 7FR COMPANION SHEATH. THERE WAS BLOOD LOSS/LEAKING FROM THE SHEATH VALVE DURING THE SUPPORTED PCI. THE TEAM HAD TO INFUSE 1 UNIT OF RED BLOOD CELLS. THE PUMP AND INTRODUCER WERE EXPLANTED AT THE CONCLUSION OF THE PCI. THE PATIENT SURVIVED THE LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319783 SHEATH, 7FR SINGLE ACCESS SHEATH INTRODUCER, CATHETER (INTRODUCER) DYB ABIOMED, INC. - 1220648

    Patients

    Seq Age Sex Outcome Treatment
    1