BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGREAT

    MDR report key: 21123975 · Received January 10, 2025

    Report

    Report Number
    9681834-2024-00260
    Event Type
    Injury
    Date Received
    January 10, 2025
    Date of Event
    December 18, 2024
    Report Date
    January 10, 2025
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQO
    PMA / PMN Number
    K033583
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: PMA/510(K): K033913. THE RETURNED ITEMS INCLUDED A PROGREAT (ACTUAL SAMPLE) ALONG WITH A GUIDEWIRE AND A Y-CONNECTOR, WHICH WERE USED IN COMBINATION WITH THE ACTUAL SAMPLE. THE COIL MENTIONED IN THE COMPLAINT WAS NOT RETURNED. THE ACTUAL SAMPLE AND THE GUIDEWIRE WERE STUCK TO EACH OTHER. [APPEARANCE INSPECTION (USING A DIGITAL MICROSCOPE AND AN X-RAY FLUOROSCOPE)]: THE ACTUAL SAMPLE HAD CRUSHES AT THREE POINTS, TEARS AT THREE POINTS, A TWISTING AND A STRETCHING IN THE CATHETER TUBE. NO SCRATCHES OR SIMILAR ABNORMALITIES WERE FOUND IN THE CRUSHED OR THE TWISTED AREAS. THE DISTAL END OF THE GUIDEWIRE WAS LOCATED AT APPROXIMATELY 940 MM FROM THE DISTAL END OF THE ACTUAL SAMPLE. THE CONSTRICTION OF LUMEN WAS OBSERVED IN THE CRUSHED AND TWISTED AREAS. THE REINFORCING COIL UNDERNEATH THE STRAIN RELIEF WAS REVEALED TO BE JUMBLED. NO OBSTRUCTION OR SIMILAR ANOMALY WAS OBSERVED IN THE OTHER SECTIONS OF THE LUMEN. [DIMENSIONS]: THE OUTER DIAMETER OF THE ACTUAL SAMPLE (UNDAMAGED AREA): DISTAL SECTION WAS 0.93 MM AND THE PROXIMAL SECTION WAS 0.96MM, WHICH MET THE FACTORY'S CONTROL CRITERIA. NO ANOMALY WAS OBSERVED. THE INNER DIAMETER OF THE ACTUAL SAMPLE (UNDAMAGED AREA): DISTAL SECTION WAS 0.69MM, WHICH MET THE FACTORY'S CONTROL CRITERIA. NO ANOMALY WAS OBSERVED. THE INNER DIAMETER AT THE TWISTED AREA WAS MEASURED TO BE 0.62 MM, WHICH IS BELOW THE MINIMUM INNER DIAMETER (0.635 MM) OF APPLICABLE MICROCATHETERS SPECIFIED IN THE COILS' PACKAGE INSERT. FROM THIS, IT WAS PROBABLE THAT THE COIL HAD BECOME DETACHED AND STUCK AT THE TWISTED AREA. NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD. NO SIMILAR REPORT FROM OTHER FACILITIES WAS FOUND IN THE PAST COMPLAINT FILE. BASED ON THE INVESTIGATION RESULT, AS A POSSIBLE CAUSE OF THIS CASE, IT WAS INFERRED THAT THE ISSUE WAS CAUSED BY THE FOLLOWING MECHANISM. DURING THE PLACEMENT OF 10 COILS, THE ACTUAL SAMPLE WAS EXPOSED TO COMPRESSION, TORQUE, AND TENSILE LOADS. AS A RESULT, THE ACTUAL SAMPLE EXPERIENCED CRUSHING, TWISTING, AND STRETCHING, WHICH ULTIMATELY RESULTED IN THE NARROWING OF THE LUMEN. THE 11TH COIL BECAME CAUGHT, SPECIFICALLY AT THE TWISTED AREA, AND AS A RESULT, IT WAS DETACHED AND STUCK. IT WAS DEDUCED THAT THE TEARS IN THE CATHETER TUBE AND THE JUMBLING OF THE REINFORCING COILS POSSIBLY HAPPENED DURING THE PROCESS OF RETRIEVING THE COIL. HOWEVER, THE EXACT TIMING OF THESE INCIDENTS COULD NOT BE DETERMINED. TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. (B)(4) IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. (B)(4).

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE FOR A SUBCLAVIAN ARTERY ANEURYSM, COILS FROM ANOTHER MANUFACTURER WERE USED ALONG WITH THE INVOLVED DEVICE. IN THE PROCESS OF PLACING THE 11TH COIL, IT BECAME DETACHED BEFORE FULLY EXITING THE DEVICE. EFFORTS WERE MADE TO PUSH THE REMAINING COIL OUT; HOWEVER, IT COULD NOT EXIT THE MICROCATHETER. SUBSEQUENTLY, AN ATTEMPT WAS MADE TO RETRIEVE THE COIL USING A SNARE; HOWEVER, IT WAS UNSUCCESSFUL. IN AN EFFORT TO REMOVE BOTH THE COIL AND THE DEVICE FROM THE PATIENT, ANOTHER ATTEMPT WAS MADE. HOWEVER, ONLY THE DEVICE WAS SUCCESSFULLY EXTRACTED, LEAVING THE COIL LODGED INSIDE THE 4 FRENCH ANGIOGRAPHIC CATHETER. A NEW APPROACH WAS TAKEN BY ACCESSING THE LEFT BRACHIAL ARTERY, AND THE COIL WAS SUCCESSFULLY RETRIEVED USING A SNARE. NO DAMAGE WAS CAUSED TO THE PATIENT'S HEALTH; HOWEVER, THE COIL WAS DEPLOYED INSIDE THE ACTUAL DEVICE, LEADING TO THE SITUATION WHERE IT WAS IMPOSSIBLE TO PRIMARILY RETRIEVE THE ACTUAL DEVICE AND THE COIL. REOCCURRENCE OF AN EVENT OF THIS NATURE WILL POTENTIALLY LEAD TO SERIOUS INJURY. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363971 PROGREAT CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO TERUMO CORPORATION, ASHITAKA MC-PV2815 231219

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown