BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANS-RAY PLUS 7.5FR 40CC IAB WITH ACCESSORIES

    MDR report key: 20398516 · Received October 8, 2024

    Report

    Report Number
    2248146-2024-0000617
    Event Type
    Malfunction
    Date Received
    October 8, 2024
    Date of Event
    September 19, 2024
    Report Date
    December 2, 2024
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567111728
    PMA / PMN Number
    K122628
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE IAB WAS RETURNED WITH THE MEMBRANE COMPLETELY UNFOLDED AND BLOOD ON THE EXTERIOR AND INTERIOR OF THE CATHETER AND BETWEEN THE CATHETER AND THE SHEATH. THE RETURNED SHEATH WAS OVER THE CATHETER AND COVERING HALF OF THE BALLOON. A KINK WAS OBSERVED ON THE CATHETER TUBING APPROXIMATELY 26.2CM FROM IAB TIP. ADDITIONALLY THE OPTICAL FIBER WAS FOUND TO BE BROKEN WITHIN THE MEMBRANE APPROXIMATELY 5.6CM FROM IAB TIP. THE INNER LUMEN WAS FOUND OCCLUDED WITH DRIED BLOOD. THE OCCLUSION WAS UNABLE TO BE CLEARED. THE OPTICAL FIBER WAS FOUND TO BE BROKEN, CONFIRMING THE REPORTED PROBLEM. WE ARE UNABLE TO DETERMINE WHEN THIS MAY HAVE OCCURRED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT. NO NONCONFORMANCES WERE FOUND THAT ARE CONSIDERED TO BE RELATED TO THE EVENT. REFERENCE COMPLAINT #(B)(4)

    Additional Manufacturer Narrative · 0

    EVENT SITE POSTAL CODE: 596-0042 THE PRODUCT HAS BEEN RETURNED TO THE MANUFACTURER, BUT IS PENDING INVESTIGATION. ONCE THE INVESTIGATION IS COMPLETED A SUPPLEMENTAL REPORT WITH OUR FINDINGS WILL BE SUBMITTED. COMPLAINT RECORD ID # (B)(4).

    Description of Event or Problem · 0

    N/A

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING INTRA-AORTIC BALLOON (IAB) THERAPY, A FIBER OPTIC SENSOR FAILURE ALARM OCCURRED. THE WAVEFORM WAS THEN OBTAINED FROM THE ARTERIAL LINE AND THERAPY WAS CONTINUED. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16666 TRANS-RAY PLUS 7.5FR 40CC IAB WITH ACCESSORIES SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0684-00-0608 3000327934 10607567111728

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown