BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSATION 7FR. 34CC IAB

    MDR report key: 16630114 · Received March 28, 2023

    Report

    Report Number
    2248146-2023-00217
    Event Type
    Malfunction
    Date Received
    March 28, 2023
    Date of Event
    February 25, 2023
    Report Date
    May 2, 2023
    Manufacturer
    DATASCOPE CORP. - FAIRFIELD
    Product Code
    DSP
    UDI-DI
    10607567106755
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT 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 WAS OVER THE CATHETER AND PARTIALLY COVERING THE REAR PORTION OF THE BALLOON.. THE OPTICAL FIBER WAS FOUND TO BE BROKEN WITHIN THE CATHETER TUBING NEAR THE Y-FITTING APPROXIMATELY 75.9CM FROM IAB TIP. 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

    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. COMPLAINT RECORD ID #(B)(4).

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER APPROXIMATELY ONE DAY OF INTRA-AORTIC BALLOON (IAB) THERAPY, THE CONSOLE GENERATED A FIBER OPTIC SENSOR FAILURE ALARM. A NEW IAB WAS INSERTED TO CONTINUE THERAPY WITHOUT FURTHER ISSUE. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28064 SENSATION 7FR. 34CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - FAIRFIELD 0684-00-0469-01 3000274576 10607567106755

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female UNKNOWN.