BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW

    MDR report key: 24578918 · Received March 12, 2026

    Report

    Report Number
    24578918
    Event Type
    Malfunction
    Date Received
    March 12, 2026
    Date of Event
    February 16, 2026
    Report Date
    March 6, 2026
    Manufacturer
    TELEFLEX INCORPORATED
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DEVICE WAS ZEROED IN THE CCL [CARDIAC CATH LAB]. BUT STILL HAD BPS [BLOOD PRESSURES] THAT DID NOT MAKE SENSE. PRESSURES DID NOT CORRELATE. THE ASSISTED PRESSURES WERE HIGHER THAN THE UNASSISTED, AND THE DIASTOLIC PRESSURE WAS OFTEN GREATER THAN THE SYSTOLIC. IABC [INTRA-AORTIC BALLOON CONSOLE] WAS REMOVED. FOLLOWING REMOVAL, THE PATIENT IMPROVED. MANUFACTURER RESPONSE FOR INTRA AORTIC BALLOON CATHETER, IAB-05840-LWS-SC - FIBEROPTIX ULTRA 8 IAB SC: 8FR 40CC (PER SITE REPORTER). DISPOSABLE SENT BACK FOR EVALUATION; AWAITING RESPONSE FROM MANUFACTURER. MANUFACTURER RESPONSE FOR INTRA AORTIC BALLOON PUMP, AC3 OPTIMUS (PER SITE REPORTER). TELEFLEX FSE WAS ON-SITE TO PERFORM FUNCTIONAL CHECK ON IABP. PUMP PERFORMED TO OEM SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638041 ARROW SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP TELEFLEX INCORPORATED

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other