BEUDAMED
    FDA Adverse Event Death Summary report: N

    SENSATION 7FR. 34CC IAB

    MDR report key: 11266027 · Received February 2, 2021

    Report

    Report Number
    2248146-2021-00060
    Event Type
    Death
    Date Received
    February 2, 2021
    Date of Event
    January 11, 2021
    Report Date
    March 19, 2021
    Manufacturer
    DATASCOPE CORP. - FAIRFIELD
    Product Code
    DSP
    UDI-DI
    10607567108605
    PMA / PMN Number
    K063525
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION: SECTION D CHANGED BRAND NAME SENSATION PLUS 8FR. 50CC IAB TO SENSATION 7FR. 34CC IAB. SECTION D CHANGED UNIQUE IDENTIFIER (UDI) #(B)(4). SECTION D CHANGED CATALOG# 0684-00-0575 TO 0684-00-0433. SECTION G CHANGED PMA/510(K)# K112327 TO K063525. DEVICE EVALUATION: THE PRODUCT WAS RETURNED WITH THE MEMBRANE COMPLETELY UNFOLDED AND TRACES OF BLOOD FOUND ON THE EXTERIOR OF THE CATHETER WITH THE ONE-WAY VALVE ATTACHED. THE CATHETER TUBING WAS OBSERVED TO BE FLATTENED ALONG ITS LENGTH. THIS MAY OCCUR IF A VACUUM IS HELD WITH THE ONE-WAY VALVE ATTACHED FOR A LONG PERIOD OF TIME ON THE CATHETER CAUSING THE CATHETER TUBING TO LOSE ITS ROUND SHAPE. AN UNDERWATER LEAK TEST OF THE BALLOON, CATHETER, Y-FITTING, EXTRACORPOREAL TUBING WAS PERFORMED AND NO LEAKS WERE DETECTED. WE WERE UNABLE TO PERFORM A LABORATORY PUMP TEST DUE THE FLATTENED CONDITION OF THE CATHETER TUBING. THE FLATTENED TUBING DID NOT ALLOW THE TEST CHAMBER TO HOLD ADEQUATE PRESSURE TO PERFORM INFLATION TEST. WE WERE UNABLE TO DUPLICATE THE REPORTED PROBLEM DUE TO THE RETURNED CONDITION OF THE IAB CATHETER. ALTHOUGH WE DID NOT REPEAT THIS EVENT IN THE LABORATORY SETTING, A FLATTENED CATHETER TUBING CAN CAUSE INFLATION DIFFICULTY OR AN ALARM. 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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FIRST INTRA-AORTIC BALLOON(IAB) NEVER MADE IT INTO THE BODY. THE BALLOON INFLATED OUTSIDE THE BODY. THE CUSTOMER TOOK ANOTHER 34CC IAB CATHETER AND IT WORKED FINE. THE PATIENT PASSED AT A LATER DATE. THIS REPORT IS FOR THE 1ST IAB USED. A SEPARATE REPORT WILL BE SUBMITTED FOR THE 2ND IAB USED.

    Additional Manufacturer Narrative · 1

    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 # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FIRST INTRA-AORTIC BALLOON(IAB) NEVER MADE IT INTO THE BODY. THE BALLOON INFLATED OUTSIDE THE BODY. THE CUSTOMER TOOK ANOTHER 34CC IAB CATHETER AND IT WORKED FINE. THE PATIENT PASSED AT A LATER DATE. THIS REPORT IS FOR THE 1ST IAB USED. A SEPARATE REPORT WILL BE SUBMITTED FOR THE 2ND IAB USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161337 SENSATION 7FR. 34CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - FAIRFIELD 0684-00-0576-01 3000127289 10607567108605

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Death