BEUDAMED
    FDA Adverse Event Death Summary report: N

    ULTRAFLEX IAB: 7.5FR 30CC

    MDR report key: 14498795 · Received May 25, 2022

    Report

    Report Number
    3010532612-2022-00185
    Event Type
    Death
    Date Received
    May 25, 2022
    Date of Event
    April 23, 2022
    Report Date
    April 27, 2022
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DSP
    UDI-DI
    00801902003751
    PMA / PMN Number
    K000729
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THERE IS AN INVESTIGATION ONGOING INTO THIS REPORTED COMPLAINT. A SUPPLEMENT FOLLOW-UP MDR REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    QN#(B)(4). TELEFLEX RECEIVED THE DEVICE FOR INVESTIGATION. THE REPORTED COMPLAINT THAT THE "BALLOON RUPTURED" IS CONFIRMED. THE INTRA-AORTIC BALLOON CATHETER (IABC) BLADDER HAD A FULL THICKNESS ABRASION, WHICH CAUSED THE BLOOD TO ENTER THE HELIUM PATHWAY. THE APPEARANCE OF THE ABRADED AREA IS CONSISTENT WITH REPEATED CONTACT WITH CALCIFIED PLAQUE ON THE AORTIC WALL. UPON FURTHER INSPECTION, AN ADDITIONAL LEAK SITE CONSISTENT WITH CONTACT FROM A SHARP OBJECT WAS NOTED ON THE IABC BLADDER AND POTENTIALLY OCCURRED AFTER OR DURING THE REMOVAL OF THE DEVICE FROM THE PATIENT. THE ROOT CAUSE OF THE BLADDER LEAK IS RELATED TO PATIENT CONDITION. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CATHETER WAS INSERTED INTO THE PATIENT ON APR. 20 AND PCI WAS DONE ON APR. 21. THERE WAS NO ABNORMALITY AT THAT TIME. ON APR. 23, THE BALLOON RUPTURED AND BLOOD ENTERED THE HELIUM PATHWAY. IT WAS NOTED THAT THE PATIENT HAD A STROKE AND LATER DIED. FROM CATHETER INSERTION TO REMOVAL, IABP ALARM WENT OFF AND IT WAS RESTARTED 9 TIMES. A TELEFLEX SALES REPRESENTATIVE MET WITH THE STAFF OF THE MEDICAL SAFETY MANAGEMENT AND THE CLINICAL ENGINEER, THEY DID NOT SAY THERE WAS A CAUSAL LINK BETWEEN THE DEVICE AND PATIENT'S DEATH. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, THE COMPLAINT WILL BE UPDATED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CATHETER WAS INSERTED INTO THE PATIENT ON (B)(6) AND PCI WAS DONE ON (B)(6). THERE WAS NO ABNORMALITY AT THAT TIME. ON (B)(6), THE BALLOON RUPTURED AND BLOOD ENTERED THE HELIUM PATHWAY. IT WAS NOTED THAT THE PATIENT HAD A STROKE AND LATER DIED. FROM CATHETER INSERTION TO REMOVAL, IABP ALARM WENT OFF AND IT WAS RESTARTED 9 TIMES. A TELEFLEX SALES REPRESENTATIVE MET WITH THE STAFF OF THE MEDICAL SAFETY MANAGEMENT AND THE CLINICAL ENGINEER, THEY DID NOT SAY THERE WAS A CAUSAL LINK BETWEEN THE DEVICE AND PATIENT'S DEATH. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, THE COMPLAINT WILL BE UPDATED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342422 ULTRAFLEX IAB: 7.5FR 30CC SYSTEM, BALLOON, INTRA-AORTIC DSP ARROW INTERNATIONAL LLC IPN000257 18F21F0013 00801902003751

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Female Death NI.| NI.