BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSATION PLUS 7.5FR. 40CC IAB

    MDR report key: 11367255 · Received February 23, 2021

    Report

    Report Number
    2248146-2021-00122
    Event Type
    Malfunction
    Date Received
    February 23, 2021
    Report Date
    April 12, 2021
    Manufacturer
    DATASCOPE CORP. - FAIRFIELD
    Product Code
    DSP
    UDI-DI
    10607567108605
    PMA / PMN Number
    K122628
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION: SECTION D CHANGED BRAND NAME SENSATION PLUS 8FR. 50CC IAB TO SENSATION PLUS 7.5FR. 40CC IAB. SECTION D CHANGED CATALOG #0684-00-0575 TO 0684-00-0567. SECTION D CHANGED UDI NUMBER (B)(4). SECTION D CHANGED LOT #3000128022 TO 3000129252. SECTION D CHANGED EXP DATE 07/23/2023 TO 08/20/2023. SECTION G CHANGED PMA/510(K)# K112327 TO K122628. SECTION H CHANGED MANUFACTURE DATE 07/23/2020 TO 08/20/2020. DEVICE EVALUATION: THE IAB WAS RETURNED WITH THE MEMBRANE COMPLETELY UNFOLDED. NO BLOOD WAS VISIBLE ON THE CATHETER. ONE KINK WAS FOUND ON THE CATHETER TUBING NEAR THE Y-FITTING APPROXIMATELY 76.2CM FROM THE IAB TIP. A SENSOR OUTPUT TEST WAS PERFORMED AND A PRESSURE READING COULD NOT BE OBTAINED. THE TECHNICIAN THEN USED AN OPTICAL LIGHT TO DETECT ANY BREAKS IN THE SENSOR'S OPTICAL FIBER AND A BREAK WAS OBSERVED WITHIN THE SENSOR CONNECTOR. THE OPTICAL FIBER WAS FOUND TO BE BROKEN, CONFIRMING THE REPORTED PROBLEMS. WE ARE UNABLE TO DETERMINE WHEN THIS MAY HAVE OCCURRED. A DEVICE AND LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT. NO NONCONFORMANCES WERE FOUND THAT ARE CONSIDERED TO BE RELATED TO THE EVENT. 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). BASED ON THE RATIONAL PROVIDED ABOVE, NO ESCALATION TO THE CAPA PROCESS IS REQUIRED. REFERENCE COMPLAINT #: (B)(4).

    Additional Manufacturer Narrative · 0

    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. REFERENCE COMPLAINT # (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING INTRA-AORTIC BALLOON (IAB) THERAPY, THE CUSTOMER WAS UNABLE TO MONITOR THE PRESSURE OR CALIBRATE THE OPTICAL SENSOR. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING INTRA-AORTIC BALLOON (IAB) THERAPY, THE CUSTOMER WAS UNABLE TO MONITOR THE PRESSURE OR CALIBRATE THE OPTICAL SENSOR. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED THAT DURING INTRA-AORTIC BALLOON (IAB) THERAPY, THE CUSTOMER WAS UNABLE TO MONITOR THE PRESSURE OR CALIBRATE THE OPTICAL SENSOR. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262651 SENSATION PLUS 7.5FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - FAIRFIELD 0684-00-0576-01 3000129252 10607567108605

    Patients

    Seq Age Sex Outcome Treatment
    1