BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANS-RAY PLUS 7.5FR 40CC IAB WITH ACCESSORIES

    MDR report key: 19031831 · Received April 3, 2024

    Report

    Report Number
    2248146-2024-00193
    Event Type
    Malfunction
    Date Received
    April 3, 2024
    Date of Event
    March 9, 2024
    Report Date
    December 18, 2024
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    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

    EVENT SITE POSTAL CODE: (B)(6). THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER SO WE ARE UNABLE TO COMPLETE AN EVALUATION. IF PROVIDED WE WILL SEND A SUPPLEMENTAL REPORT WITH OUR ADDITIONAL FINDINGS. REFERENCE COMPLAINT #1002114 H3 OTHER TEXT : DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 0

    UDI RELATED DATA QUALITY UPDATES ONLY. PROVIDING UPDATED DEVICE IDENTIFICATION INFORMATION IN ALIGNMENT WITH GUDID. UDI # IS INCOMPLETE AS THE CATALOG#, LOT #, MANUFACTURE DATE, EXP. DATE WERE NOT PROVIDED. THIS INFORMATION WAS REQUESTED FROM THE CUSTOMER; HOWEVER, DESPITE OUR BEST EFFORTS, NO INFORMATION HAS BEEN RECEIVED. IF ANY PERTINENT INFORMATION IS RECEIVED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED COMPLAINT RECORD ID # (B)(4).

    Additional Manufacturer Narrative · 0

    A PORTION OF THE CATHETER TUBING AND MEMBRANE WAS RETURNED WITH THE MEMBRANE COMPLETELY UNFOLDED AND BLOOD ON THE EXTERIOR OF THE CATHETER AND BETWEEN THE CATHETER AND THE SHEATH. THE RETURNED SHEATH TUBING WAS OBSERVED TO BE RIBBED ALONG ITS LENGTH. THE RETURNED SHEATH WAS NOT A MAQUET PRODUCT. A NON MAQUET GUIDE WIRE WAS ALSO RETURNED. THE SENSOR CABLE WAS CUT FROM THE IAB AND NOT RETURNED. NO KINKS WERE OBSERVED ON THE RETURNED DEVICE. THE REPORTED KINK CANNOT BE CONFIRMED BY THE EVALUATION. HOWEVER, WE ARE UNABLE TO CONCLUSIVELY DETERMINE THE PRESENCE OF A KINK DUE TO PORTION OF THE IAB NOT RETURNED. REFERENCE COMPLAINT #(B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING INTRA-AORTIC BALLOON (IAB) THERAPY, A "KINK" ALARM OCCURRED FREQUENTLY AFTER A CT SCAN. THE IAB WAS REPLACED AND THERAPY WAS PROVIDED. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1607630 TRANS-RAY PLUS 7.5FR 40CC IAB WITH ACCESSORIES SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0684-00-0608 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown