BEUDAMED
    FDA Adverse Event Death Summary report: N

    REDIGUARD IAB: 7FR 30CC

    MDR report key: 11630347 · Received April 7, 2021

    Report

    Report Number
    3010532612-2021-00104
    Event Type
    Death
    Date Received
    April 7, 2021
    Date of Event
    March 3, 2021
    Report Date
    March 9, 2021
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DSP
    UDI-DI
    00801902002686
    PMA / PMN Number
    K981660
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    QN# (B)(4). TELEFLEX RECEIVED THE DEVICE FOR INVESTIGATION. THE REPORTED COMPLAINT OF IAB BLOOD IN HELIUM PATHWAY IS NOT CONFIRMED. DURING THE VISUAL INSPECTION OF THE RETURNED SAMPLE, NO BLOOD WAS NOTED WITHIN THE HELIUM PATHWAY. THE RETURNED INTRA-AORTIC BALLOON CATHETER (IABC) BLADDER WAS FULLY INTACT WITH NO ABNORMALITIES NOTED. NO ALARMS WERE NOTED DURING THE FUNCTIONAL TESTING. THE RETURNED DEVICE PASSED VISUAL AND FUNCTIONAL TEST SPECIFICATIONS. THE ROOT CAUSE OF THE COMPLAINT IS UNDETERMINED. ADDITIONALLY, AN IN-SERVICE HAS BEEN REQUESTED TO THE CUSTOMER DUE THE EVENT INFORMATION RECEIVED/REVIEWED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE LOT NUMBER WITH NO RELEVANT FINDINGS. THE DEVICE PASSED ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. TELEFLEX ASSESSED THE RISK FOR THE REPORTED COMPLAINT. THERE ARE NO NEW OR REVIVED RISK. THIS WILL BE MONITORED FOR ANY DEVELOPING TRENDS.

    Additional Manufacturer Narrative · 0

    QN# (B)(4). TELEFLEX RECEIVED THE DEVICE FOR INVESTIGATION. THE REPORTED COMPLAINT OF IAB BLOOD IN HELIUM PATHWAY IS NOT CONFIRMED. DURING THE VISUAL INSPECTION OF THE RETURNED SAMPLE, NO BLOOD WAS NOTED WITHIN THE HELIUM PATHWAY. THE RETURNED INTRA-AORTIC BALLOON CATHETER (IABC) BLADDER WAS FULLY INTACT WITH NO ABNORMALITIES NOTED. NO ALARMS WERE NOTED DURING THE FUNCTIONAL TESTING. THE RETURNED DEVICE PASSED VISUAL AND FUNCTIONAL TEST SPECIFICATIONS. THE ROOT CAUSE OF THE COMPLAINT IS UNDETERMINED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE LOT NUMBER WITH NO RELEVANT FINDINGS. THE DEVICE PASSED ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. TELEFLEX ASSESSED THE RISK FOR THE REPORTED COMPLAINT. THERE ARE NO NEW OR REVISED RISK. THIS WILL BE MONITORED FOR ANY DEVELOPING TRENDS. THERE WAS EVIDENCE THAT THE INSTRUCTIONS FOR USE AND EXPECTED OPERATION OF THE PUMP WERE NOT FOLLOWED. AN IN-SERVICE WAS REQUESTED ON (B)(6) 2021 AND COMPLETED ON (B)(6) 2021. THIS WAS REQUESTED TO REVIEW IABP RECOMMENDED TROUBLESHOOTING IN THE EVENT OF A POSSIBLE BALLOON RUPTURE AND THE INSTRUCTIONS FOR USE OF THE IABC. OTHER REMARKS: THE PATIENT WAS ADMITTED TO THE RAJIV GANDHI GOVERNMENT HOSPITAL TO UNDERGO CORONARY ARTERY BYPASS SURGERY AFTER AN ACUTE MYOCARDIAL INFARCTION. THE PATIENT WAS NOTED TO HAVE A LOW CARDIAC OUTPUT. AT SOME POINT IN THE EVENING ON (B)(6) 2021, IABP (INTRA-AORTIC BALLOON PUMP) THERAPY WAS STARTED TO STABILIZE HEMODYNAMICS. APPROXIMATELY 6 HOURS LATER, THE PUMP ALARMED FOR POSSIBLE HELIUM LOSS. ALL CONNECTIONS BETWEEN THE PUMP AND THE IABC (INTRA-AORTIC BALLOON CATHETER) WAS CHECKED AND NO BLOOD WAS NOTED IN THE HELIUM DRIVELINE TUBING. THIS TOOK APPROXIMATELY 3-5 MINUTES. STAFF ATTEMPTED TO RESTART THERAPY, AND THE PUMP ALARMED AGAIN FOR POSSIBLE HELIUM LOSS. AT THIS POINT THERE WAS NO BACKUP PUMP AVAILABLE, SO THEY REQUESTED A NEW PUMP FROM THEIR SERVICE PARTNER. THE IABC REMAINED IN THE PATIENT FOR 3-4 HOURS WHILE A BACKUP PUMP WAS BROUGHT TO THE HOSPITAL. MEANWHILE, A TECHNICIAN ATTEMPTED 5-6 TIMES TO RESTART THE PUMP AND EACH TIME RECEIVED POSSIBLE HELIUM LOSS ALARMS. AFTER THE NEW PUMP ARRIVED, IT WAS CONNECTED, AND THE PUMP IMMEDIATELY ALARMED FOR POSSIBLE HELIUM LOSS. THE IABC WAS THEN IMMEDIATELY REPLACED SUCCESSFULLY WITH THE SAME INSERTION SITE. THE 2ND IABC SUCCESSFULLY CONTINUED THERAPY FOR >24 HOURS UNTIL THE PATIENT DIED. ACCORDING TO FOLLOW-UP INFORMATION RECEIVED, A POTENTIAL CAUSE OF DEATH WAS A HEMORRHAGE RELATED TO THE ADMINISTRATION OF HEPARIN AS A SUPPORTIVE THERAPY CONCURRENT TO IABP THERAPY. SYSTEMIC HEPARIN IS ADMINISTERED AS A PHYSICIAN'S DECISION AND OUR INSTRUCTIONS FOR USE RECOMMENDS THE SUSPENSION OR TAPERING OF ANTICOAGULATION THERAPY AS WELL AS IMMEDIATE REMOVAL OF THE IABC AFTER A SUSPECTED BALLOON PERFORATION. THERE WAS EVIDENCE THAT THE INSTRUCTIONS FOR USE AND EXPECTED OPERATION OF THE PUMP WERE NOT FOLLOWED. AN IN-SERVICE WAS REQUESTED ON (B)(6) 2021 AND COMPLETED ON (B)(6) 2021. THIS WAS REQUESTED TO REVIEW IABP RECOMMENDED TROUBLESHOOTING IN THE EVENT OF A POSSIBLE BALLOON RUPTURE AND THE INSTRUCTIONS FOR USE OF THE IABC. (B)(6) ORIGINALLY STATED THAT THE IABC "MAY BE" CAUSED OR CONTRIBUTED TO THE DEATH DUE TO "LOW CARDIAC OUTPUT." UPON FOLLOW-UP, (B)(6) STATED "IABC FAILURE WAS CONTRIBUTORY IN THAT EVENT PATIENT HAD BLOOD LEAKING INSIDE THE VESSEL BECAUSE OF HEPARIN."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN THE INTRA-AORTIC BALLOON (IAB) WAS IN USE, THAT STAFF EXPERIENCED A, "POSSIBLE HELIUM LOSS" ALARM AND THE IAB STOPPED FUNCTIONING. IN ADDITION, THE STAFF ALSO NOTED THAT BLOOD ENTERED THE VESSEL. AS A RESULT, A NEW IAB WAS USED, AND THERAPY CONTINUED FOR ANOTHER 24 HOURS, HOWEVER THE PATIENT DIED. (B)(6) CONFIRMED THAT THE DEVICE CAUSE/CONTRIBUTED TO PATIENT'S DEATH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN THE INTRA-AORTIC BALLOON (IAB) WAS IN USE, THAT STAFF EXPERIENCED A, "POSSIBLE HELIUM LOSS" ALARM AND THE IAB STOPPED FUNCTIONING. IN ADDITION, THE STAFF ALSO NOTED THAT BLOOD ENTERED THE VESSEL. AS A RESULT, A NEW IAB WAS USED, AND THERAPY CONTINUED FOR ANOTHER 24 HOURS, HOWEVER THE PATIENT DIED. (B)(6) CONFIRMED THAT THE DEVICE CAUSE/CONTRIBUTED TO PATIENT'S DEATH.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE INTRA-AORTIC BALLOON (IAB) WAS IN USE, THAT STAFF EXPERIENCED A, "POSSIBLE HELIUM LOSS" ALARM AND THE IAB STOPPED FUNCTIONING. IN ADDITION, THE STAFF ALSO NOTED THAT BLOOD ENTERED THE VESSEL. AS A RESULT, A NEW IAB WAS USED, AND THERAPY CONTINUED FOR ANOTHER 24 HOURS, HOWEVER THE PATIENT DIED. DR. (B)(6) CONFIRMED THAT THE DEVICE CAUSE/CONTRIBUTED TO PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527926 REDIGUARD IAB: 7FR 30CC SYSTEM, BALLOON, INTRA-AORTIC DSP ARROW INTERNATIONAL INC. IPN000262 18F19K0004 00801902002686

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death