BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW ULTRAFLEX IAB: 7.5FR 40CC

    MDR report key: 22297125 · Received June 20, 2025

    Report

    Report Number
    3010532612-2025-00558
    Event Type
    Malfunction
    Date Received
    June 20, 2025
    Date of Event
    April 18, 2025
    Report Date
    May 26, 2025
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DSP
    UDI-DI
    00801902026804
    PMA / PMN Number
    K000729
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    QN #: (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4) THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. THE CUSTOMER PHOTOS WERE REVIEWED. THE PHOTOS SHOW A CARDIAC CATHETERIZATION LAB REPORT. THE PHOTO SHOWS THE ORIGINAL PACKAGING LABEL WITH A SERIAL NUMBER THAT MATCHES THE REPORTED SERIAL NUMBER. THE PHOTO SHOWS A DAMAGED IAB CATHETER IN A TEFLON SHEATH; THE IAB DISTAL TIP WAS NOTED STUCK, AND THE CENTRAL LUMEN WAS NOTED UNRAVELED. IN THE PHOTO (PIC1), THE TEFLON SHEATH EXTRUSION WAS NOTED DAMAGED, CONSISTENT WITH BEING BUCKLED AND THE SHEATH WAS NOTED ON THE DEVICE IN QUESTION. THE CONDITIONS OF THE TEFLON SHEATH NOTED IN THE PHOTO INDICATES THAT THE USER WITHDREW THE IABC THROUGH THE SHEATH. AS A RESULT, AN IN-SERVICE HAS BEEN REQUESTED TO REVIEW THE INSTRUCTIONS FOR USE (IFU) WITH THE CUSTOMER. THE INSTRUCTIONS FOR USE (IFU) STATES: "DO NOT REMOVE ARROW IAB THROUGH HEMOSTASIS SHEATH INTRODUCER OR HEMOSTASIS DEVICE. ONCE UNWRAPPED (UNFURLED), BALLOON PROFILE WILL NOT ALLOW PASSAGE THROUGH THE SHEATH AND ATTEMPTED REMOVAL IN THIS MANNER MAY RESULT IN ARTERIAL TEARING, DISSECTION OR BALLOON DAMAGE." 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. THE REPORTED COMPLAINT FOR CATHETER STUCK IN SHEATH IS CONFIRMED BASED ON THE SUBMITTED PHOTO. THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. THE PHOTO SHOWS AN IAB CATHETER STUCK IN THE TEFLON SHEATH. THE CATHETER AND SHEATH WERE NOTED DAMAGED IN THE PHOTO. ADDITIONALLY, ACCORDING TO THE EVENT DETAILS, AFTER CATHETER IMPLANTATION THE USER ATTEMPTED TO WITHDRAW THE CATHETER THROUGH THE SHEATH. AS A RESULT, AN IN-SERVICE HAS BEEN REQUESTED TO REVIEW THE INSTRUCTIONS FOR USE (IFU) WITH THE CUSTOMER. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD (DHR), THE PRODUCT MET SPECIFICATION UPON RELEASE; HOWEVER, THE SPECIFICATIONS WERE NOT MET DUE TO THE CATHETER BEING STUCK IN THE SHEATH. THE ROOT CAUSE OF THE COMPLAINT IS UNDETERMINED. NO FURTHER ACTION IS REQUIRED AT THIS TIME. THE REPORTED COMPLAINT WILL BE MONITORED FOR ANY DEVELOPING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED, "INSERT IABP SHEATH VIA LEFT FEMORAL ARTERY PASS IABP WIRE NORMALLY BUT UNABLE TO INSERT IABP BALLOON TO THE APPROPRIATE POSITION. INSERT IABC ONLY ABOUT ABDOMINAL AORTA. CAN NOT INSERT AGAIN. SO DECIDED TO PULL IT OUT BUT UNABLE TO PULL IT OUT. IABC STUCK + WIRE STRUK AT ABDOMINAL AORTA. MUST PULL OUT BOTH WITH WIRE + IABC SHEATH". ADDITIONAL INFORMAITON STATES THAT THE IAB CATHETER WAS REPLACED. NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "CRITICAL".

    Description of Event or Problem · 0

    IT WAS REPORTED " INSERT IABP SHEATH VIA LEFT FEMORAL ARTERY PASS IABP WIRE NORMALLY BUT UNABLE TO INSERT IABP BALLOON TO THE APPROPRIATE POSITION. INSERT IABC ONLY ABOUT ABDOMINAL AORTA. CAN NOT INSERT AGAIN. SO DECIDED TO PULL IT OUT BUT UNABLE TO PULL IT OUT. IABC STUCK + WIRE STRUK AT ABDOMINAL AORTA. MUST PULL OUT BOTH WITH WIRE + IABC SHEATH". ADDITIONAL INFORMATION STATES THAT THE IAB CATHETER WAS REPLACED. NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS " CRITICAL".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1670790 ARROW ULTRAFLEX IAB: 7.5FR 40CC SYSTEM, BALLOON, INTRA-AORTIC DSP ARROW INTERNATIONAL LLC 18F23L0030 00801902026804

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown