BEUDAMED
    FDA Adverse Event Death Summary report: N

    TR BAND

    MDR report key: 5868029 · Received August 11, 2016

    Report

    Report Number
    9681834-2016-00190
    Event Type
    Death
    Date Received
    August 11, 2016
    Date of Event
    January 25, 2016
    Report Date
    August 11, 2016
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DXC
    PMA / PMN Number
    K070423
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D4 - UDI NO. - UDI NOT YET REQUIRED FOR THIS PRODUCT. THE ACTUAL DEVICE WAS NOT RETURNED TO THE USER FACILITY FOR EVALUATION AND THE PRODUCT CODE AND PRODUCTION LOT NUMBER ARE UNKNOWN. THEREFORE, THE INVESTIGATION WAS LIMITED TO EVALUATION OF THE USER FACILITY INFORMATION. SINCE THE PRODUCT CODE AND PRODUCTION LOT NUMBER WERE NOT PROVIDED BY THE USER FACILITY, A MEANINGFUL REVIEW OF PRODUCTION AND COMPLAINT RECORDS COULD NOT BE CONDUCTED. THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. THE EXACT CAUSE OF THE COMPLAINT CANNOT BE DEFINITIVELY DETERMINED. BASED ON THE COMPLAINT DESCRIPTION, IT IS LIKELY THAT AIR WAS INJECTED INTO THE RADIAL ARTERY, RESULTING IN THE REPORTED CEREBRAL AIR EMBOLISM. HOWEVER, IT IS UNLIKELY THAT THE INVOLVED TR-BAND INFLATOR IS THE COMPONENT THAT WAS USED TO INJECT AIR INTO THE RADIAL ARTERY SINCE ITS DISTAL TIP IS DESIGNED NOT TO BE USED ON OTHER DEVICES OR INSERTED INTO A CONVENTIONAL LUER TAPERED PORT. THE DEVICE LABELING HAS THE FOLLOWING INDICATIONS BY STATING IN THE INSTRUCTIONS-FOR-USE (IFU): 1) DO NOT INJECT AIR INTO ANY PORT OTHER THAN THE AIR INJECTION PORT OF THIS DEVICE. THIS COULD CAUSE ARTERIAL OR VENOUS EMBOLIZATION. 2) DO NOT USE THE TR BAND INFLATOR FOR OTHER PURPOSES THAN TO INFLATE THE TR BAND. IT IS NOT DESIGNED FOR OTHER PURPOSES. TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834. EXEMPTION NUMBER E2015022. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE AT THE MANUFACTURING FACILITY FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP. - ATTACHMENT: [MW5062838.PDF] H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER

    Description of Event or Problem · 0

    PER THE ATTACHED MEDWATCH MW5062838 RECEIVED FROM THE FDA ON JULY 12TH 2016, THE EVENT DESCRIPTION STATES THE FOLLOWING: "CEREBRAL AIR EMBOLISM WITH MASSIVE CVA, LIKELY CAUSE: PHYSICIAN ERROR. INJECTION OF AIR INTO RADIAL ARTERY AT TIME OF FLUSHING. THIS WAS PRIOR TO INFLATION OF TR BAND. THE TR BAND HAS A PRODUCT SPECIFIC SYRINGE FOR INFLATION THAT CANNOT BE USED ON OTHER DEVICES. THERE IS A GREEN LABEL SPECIFYING "EXCLUSIVELY FOR AIR INJECTION PORT." THERE COULD HAVE BEEN CONFUSION ON THE PART OF THE PHYSICIAN. THE RADIAL ARTERY SHEATH HAS A STOPCOCK, AND WILL ACCEPT STANDARD "SLIP TIP, OR "LUER LOCK" SYRINGES WHEN USED FOR ASPIRATION/FLUSHING. THE TR BAND SYRINGE WITH THE WARNING LABEL WILL NOT FIT INTO THE SHEATH STOPCOCK. AFTER THE DIAGNOSIS OF LARGE CVA DUE TO AIR EMBOLISM, THE PATIENT WAS HELICOPTERED OUT TO ((B)(6) FOR TREATMENT IN THE HYPERBARIC OXYGEN CHAMBER. AIR EMBOLI WERE VISUALIZED IN THE RIGHT FRONTAL, PARIETAL AND TEMPORAL LOBES. HE SHOWED NO RECOVERY. HE WAS TRANSFERRED BACK TO (B)(6), EVENTUALLY PLACED ON COMFORT CARE. THIS WAS RADIAL ARTERY SHEATH INTO WHICH AIR WAS INADVERTENTLY INJECTED AT TIME OF FLUSHING."

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THE FOLLOWING ADDITIONAL INFORMATION: IT IS UNKNOWN IF THE TR BAND INFLATOR WAS USED TO INJECT THE AIR OR A DIFFERENT SYRINGE; AND IT WAS REPORTED THAT IT WAS LIKELY THE SIDE-PORT OF THE SHEATH THAT AIR WAS INJECTED INTO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522938 TR BAND CLAMP, VASCULAR DXC TERUMO CORPORATION, ASHITAKA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death GUIDE CATHETER| MERIT MEDICAL MINI ACCESS SHEATH| PSI-6F-7018| WIRE| PSI-6F-7018