BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAFLEX IAB: 7.5FR 40CC

    MDR report key: 16407741 · Received February 21, 2023

    Report

    Report Number
    3010532612-2023-00094
    Event Type
    Injury
    Date Received
    February 21, 2023
    Date of Event
    December 30, 2022
    Report Date
    February 6, 2023
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DSP
    UDI-DI
    10801902161946
    PMA / PMN Number
    K000729
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. WITHOUT THE DEVICE TO EVALUATE, THE COMPLAINT COULD NOT BE CONFIRMED, AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE. OTHER REMARKS: N/A. CORRECTED DATA: N/A.

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WERE THREE DIFFERENT EVENTS ON THREE DIFFERENT PATIENTS IN THE LAST SIX MONTHS. THE REPORT STATES, "IN OC TOBER 2022 THE PATIENT HAD A VENTRICULAR TACHYCARDIA (VT) ARREST, CARDIOGENIC SHOCK, AND WAS LISTED FOR HEART TRANSPLANT. ADMITTED ON (B)(6)22 FOR ADVANCED THERAPIES AND VAD/TRANSPLANT EVALUATION. ON (B)(6)22, AN ULTRA FLEX 7F 40 CC IABP PLACED IN THE RIGHT FEMORAL ARTERY FOR WORSENING CARDIOGENIC SHOCK. THE PATIENT WAS HEPARINIZED WITH THERAPEUTIC ANTI-XA AND THE PATIENT WAS ON 1:1 IABP. LATER THAT DAY, THE PATIENT DEVELOPED ABDOMINAL PAIN, WHICH WAS FOUND ON CTA TO BE SECONDARY TO ARTERIAL THROMBI IN THE RIGHT HEPATIC ARTERY AND ITS PROXIMAL BRANCHES AND IN SEGMENTAL BRANCHES OF THE LEFT KIDNEY, WITH MULTIPLE RENAL INFARCTS. ON (B)(6)22, THE IABP WAS DISCONTINUED DUE TO THROMBOTIC/EMBOLIC COMPLICATIONS - IABP-RELATED ARTERIAL EMBOLISM. HE ALSO DEVELOPED LOSS OF DISTAL PULSES IN THE RIGHT LOWER EXTREMITY REQUIRING SURGERY AS BELOW. HEPARIN INDUCED THROMBOCYTOPENIA WAS THOUGHT TO BE UNLIKELY AFTER CLINICAL AND LABORATORY ASSESSMENT. THE PATIENT WAS ANTICOAGULATED WITH BIVALRUDIN. HE HAD WORSENING ACUTE KIDNEY INJURY ON CHRONIC KIDNEY INJURY. ANOTHER BALLOON WAS NOT USED. ON (B)(6)23, THE PATIENT UNDERWENT AN EMBOLECTOMY/THROMBECTOMY OF THE RIGHT LEG. ON (B)(6)23, A BIVENTRICULAR ASSIST DEVICE (BIVAD) WAS PLACED. THE PATIENT IS CURRENTLY STILL ADMITTED".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WERE THREE DIFFERENT EVENTS ON THREE DIFFERENT PATIENTS IN THE LAST SIX MONTHS. THE REPORT STATES, "IN OC TOBER 2022 THE PATIENT HAD A VENTRICULAR TACHYCARDIA (VT) ARREST, CARDIOGENIC SHOCK, AND WAS LISTED FOR HEART TRANSPLANT. ADMITTED ON 12/4/22 FOR ADVANCED THERAPIES AND VAD/TRANSPLANT EVALUATION. ON (B)(6) 2022, AN ULTRA FLEX 7F 40 CC IABP PLACED IN THE RIGHT FEMORAL ARTERY FOR WORSENING CARDIOGENIC SHOCK. THE PATIENT WAS HEPARINIZED WITH THERAPEUTIC ANTI-XA AND THE PATIENT WAS ON 1:1 IABP. LATER THAT DAY, THE PATIENT DEVELOPED ABDOMINAL PAIN, WHICH WAS FOUND ON CTA TO BE SECONDARY TO ARTERIAL THROMBI IN THE RIGHT HEPATIC ARTERY AND ITS PROXIMAL BRANCHES AND IN SEGMENTAL BRANCHES OF THE LEFT KIDNEY, WITH MULTIPLE RENAL INFARCTS. ON 12/31/22, THE IABP WAS DISCONTINUED DUE TO THROMBOTIC/EMBOLIC COMPLICATIONS - IABP-RELATED ARTERIAL EMBOLISM. HE ALSO DEVELOPED LOSS OF DISTAL PULSES IN THE RIGHT LOWER EXTREMITY REQUIRING SURGERY AS BELOW. HEPARIN INDUCED THROMBOCYTOPENIA WAS THOUGHT TO BE UNLIKELY AFTER CLINICAL AND LABORATORY ASSESSMENT. THE PATIENT WAS ANTICOAGULATED WITH BIVALRUDIN. HE HAD WORSENING ACUTE KIDNEY INJURY ON CHRONIC KIDNEY INJURY. ANOTHER BALLOON WAS NOT USED. ON 1/3/23, THE PATIENT UNDERWENT AN EMBOLECTOMY/THROMBECTOMY OF THE RIGHT LEG. ON 1/10/23, A BIVENTRICULAR ASSIST DEVICE (BIVAD) WAS PLACED. THE PATIENT IS CURRENTLY STILL ADMITTED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    926607 ULTRAFLEX IAB: 7.5FR 40CC SYSTEM, BALLOON, INTRA-AORTIC DSP ARROW INTERNATIONAL LLC IPN915322 UNKNOWN 10801902161946

    Patients

    Seq Age Sex Outcome Treatment
    1 Male