BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP 371 14F LT CMR SET

    MDR report key: 24112169 · Received January 19, 2026

    Report

    Report Number
    1220648-2026-01082
    Event Type
    Injury
    Date Received
    January 19, 2026
    Date of Event
    November 18, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502011876
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO PRODUCT RETURNED. HEMATOMA/ASAE: THROUGHOUT SUPPORT, PATIENT HAD GROIN BLEEDING AND HEMATOMA, NOT RESOLVED WITH MANUAL PRESSURE. ISSUE WAS SUCCESSFULLY MANAGED BY TIGHTENING THE PERCLOSE, STOPPING HEPARIN, AND ADDING ADDITIONAL SUTURES. THE CAUSE OF THE ACCESS SITE ADVERSE EVENT WAS USE RELATED AS THE GROIN SITE REQUIRED TIGHTENING THE PERCLOSE, ADDING ADDITIONAL SUTURES, AND STOPPING HEPARIN IN ORDER TO IMPROVE THE ISSUE. DEVICE HISTORY LOT: DEVICE LOT: 1991886. DEVICE HISTORY BATCH: SUBCOMPONENT LOT: N/A. DEVICE HISTORY REVIEW: THIS PUMP SN (B)(6) PASSED ALL POST STERILE INSPECTION CHECKS.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT A PATIENT WAS IMPLANTED WITH AN IMPELLA DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. THE TREATMENT PLAN INCLUDED RESTING THE HEART AND MANAGING THE PATIENT¿S REFRACTORY TACHYARRHYTHMIA. THE PATIENT EXPERIENCED INTERMITTENT LOSS OF AORTIC PULSATILITY. ALTHOUGH THE PATIENT¿S VOLUME STATUS HAD IMPROVED, OOZING PERSISTED AT THE IMPELLA INSERTION SITE. MANUAL COMPRESSION WAS CONTINUED WITHOUT SUCCESS, AND THE TEAM CONSIDERED TIGHTENING THE PERCLOSE DEVICE. THE PATIENT SURVIVED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173512 PUMP 371 14F LT CMR SET TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 PUMP 371 14F LT CMR SET 2026761490 00813502011876

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Required Intervention