BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANS-RAY PLUS 7.5FR 35CC IAB WITH ACCESSORIES

    MDR report key: 22663724 · Received July 30, 2025

    Report

    Report Number
    2248146-2025-0000436
    Event Type
    Malfunction
    Date Received
    July 30, 2025
    Date of Event
    July 16, 2025
    Report Date
    June 2, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567111711
    PMA / PMN Number
    K122628
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO DECON OR VISUAL INSPECTION PERFORMED SINCE PRODUCT WAS NOT RETURNED AND COULD NOT BE EVALUATED. THE VIDEO FROM THE FACILITY SHOWS AN X-RAY OF THE IAB INSIDE OF THE PATIENT, WHICH CONFIRMS THE REPORTED FAILURE. WE ARE UNABLE TO DETERMINE WHEN THIS MAY HAVE OCCURRED. HEALTH HAZARD EVALUATION (HHE) 1139208 CAPA (1163322) WAS INITIATED TO INVESTIGATE COMPLAINTS WITH FAILURE MODES OF "IAB - MARKER MISALIGNED". THE FAILURE MODE IS ADDRESSED IN THE RISK FILE AND IS OPERATING WITHIN ITS RISK PROFILE. THE IFU ADDRESSES THE REPORTED FAILURE. THERE WERE NO NCMRS IDENTIFIED WHICH COULD CAUSE OR CONTRIBUTE TO THE REPORTED FAILURE. THE INVESTIGATION DOES NOT INDICATE THAT THE DEVICE WAS INADVERTENTLY RELEASED AS NON-CONFORMING OR AN ADULTERATED PRODUCT OR WAS A COUNTERFEIT. THE COMPLAINT HISTORY REVIEW DID NOT IDENTIFY AN ADVERSE TREND (INCREASE IN NUMBER OF COMPLAINTS OVER PAST THREE (3) MONTHS).

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, E1 (INITIAL REPORTER, EVENT SITE EMAIL), E3, G3, G6, H2, H11. CORRECTED FIELDS: H6 (TYPE OF INVESTIGATION, INVESTIGATION CONCLUSIONS).

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER LIMIT IN BLOCK E1, EVENT SITE NAME: (B)(6). EVENT SITE ADDRESS: (B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 0

    N.A.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING INTRA-AORTIC BALLOON THERAPY THAT AFTER INSERTING THE TRP3546 AND CHECKING THE PLACEMENT, IT WAS NOTICED THAT THE BALLOON TIP AND THE MARKER AT THE BASE WERE TOO CLOSE. THE PROCEDURE WAS STOPPED, AND THE DEVICE WAS REPLACED WITH THE SAME TYPE AND SIZE PRODUCT. PUMPING WAS RESUMED WITHOUT AFFECTING THE PATIENT¿S HEALTH. THE ACTUAL PRODUCT WAS RETAINED FOR EVALUATION TO CHECK IF THE MARKER AT THE BASE HAD MOVED AND TO INVESTIGATE THE CAUSE OF THE PROBLEM. NO HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549614 TRANS-RAY PLUS 7.5FR 35CC IAB WITH ACCESSORIES SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0684-00-0607 3000381392 10607567111711

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male UNKNOWN.