BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIFOCUS GLIDECATH

    MDR report key: 19666411 · Received July 3, 2024

    Report

    Report Number
    9681834-2024-00109
    Event Type
    Injury
    Date Received
    July 3, 2024
    Date of Event
    June 6, 2024
    Report Date
    July 3, 2024
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQO
    PMA / PMN Number
    K090040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. G4: 510(K) NUMBER: K915414 THE ACTUAL DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. HISTORY INVESTIGATION OF THE INVOLVED PRODUCT CODE AND LOT NUMBER - NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD. - NO OTHER SIMILAR REPORT WAS FOUND IN THE PAST COMPLAINT FILE. TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SENT AS FOLLOW-UP NO. 1 TO UPDATE SECTION D9, SECTION H3, AND TO PROVIDE THE COMPLETED INVESTIGATION RESULTS. THE ACTUAL DEVICE HAS BEEN RETURNED FOR EVALUATION. 1. SAMPLES RETURNED: THE MAIN BODY OF THE ACTUAL SAMPLE. ONE FRAGMENT OF THE ACTUAL SAMPLE. ONE 4FR SHEATH. ONE SNARE FROM ANOTHER MANUFACTURER. ONE TORQUE DEVICE FROM ANOTHER MANUFACTURER. 2. CONFIRMATION OF MISSING LENGTH: THE LENGTH OF THE MAIN BODY: APPROXIMATELY 953 MM. THE LENGTH OF THE FRAGMENT: APPROXIMATELY 51 MM. THE TOTAL LENGTH OF THE MAIN BODY AND THE FRAGMENT WAS APPROXIMATELY 1004 MM, WHICH WAS WITHIN THE CONTROL STANDARD OF THE EFFECTIVE LENGTH. THIS INDICATED THAT THERE WAS NO PORTION MISSING FROM THE ACTUAL SAMPLE. 3. APPEARANCE CONFIRMATION (VISUAL AND MAGNIFYING INSPECTIONS) [MAIN BODY] THE DISTAL END HAD BEEN FRACTURED. THE EDGE OF THE FRACTURED PART WAS SHAPED LIKE A TRUMPET. A DEFORMATION AND STRETCHING WERE OBSERVED ON THE TOP SURFACE OF THE FRACTURE. NO ANOMALY WAS FOUND IN OTHER SECTIONS. [FRAGMENT] A DEFORMATION AND STRETCHING WERE OBSERVED ON THE TOP SURFACE OF THE FRACTURED PART. 4. DIMENSIONS OF THE ACTUAL SAMPLE THE INNER DIAMETER AT THE DISTAL END AND THE OUTER DIAMETER AT THE INTERMEDIATE PART WERE CONFIRMED TO MEET THE FACTORY'S SPECIFICATIONS. NO ANOMALY WAS OBSERVED. 5. SIMULATION TEST : TEST METHOD: THE DISTAL END OF A TEST SAMPLE WAS HELD, AND A BENDING LOAD WAS APPLIED TO CAUSE THE TEST SAMPLE TO KINK. FOLLOWING THAT, A TENSILE LOAD WAS APPLIED TO THE TEST SAMPLE IN THE DIRECTION OF WITHDRAWAL. TEST RESULT: A FRACTURE OCCURRED AT THE KINKED PART. THE EDGE OF THE FRACTURED PART WAS SHAPED LIKE A TRUMPET. A DEFORMATION AND STRETCHING WERE OBSERVED ON THE TOP SURFACE OF THE FRACTURED PART. 6. CAUSE OF OCCURRENCE: THERE WERE NO ANOMALIES IN THE MANUFACTURING HISTORY AND PRODUCT DIMENSIONS. BASED ON THE CONDITION OF THE ACTUAL SAMPLE, ONE POSSIBLE MECHANISM FOR THE FRACTURE CAN BE INFERRED. IT IS POSSIBLE THAT WHEN THE ACTUAL SAMPLE BECAME STUCK DUE TO CERTAIN FACTORS, A BENDING LOAD WAS APPLIED, RESULTING IN A KINK. SUBSEQUENTLY, WHEN THE ACTUAL SAMPLE WAS PULLED FOR REMOVAL WHILE STILL IN THE STUCK STATE, IT FRACTURED. HOWEVER, IT WAS NOT POSSIBLE TO DETERMINE THE SPECIFIC FACTORS THAT CAUSED THE ACTUAL SAMPLE TO BECOME STUCK OR THE APPLICATION OF THE BENDING LOAD. RELEVANT IFU REFERENCE: "NEVER ADVANCE OR WITHDRAW AN INTRALUMINAL DEVICE AGAINST RESISTANCE UNTIL THE CAUSE OF RESISTANCE IS DETERMINED BY FLUOROSCOPY. FAILURE TO EXERCISE PROPER CAUTION MAY RESULT IN DAMAGE TO THE VESSEL OR CATHETER. SEPARATION OF THE CATHETER MAY OCCUR REQUIRING RETRIEVAL IN SOME CASES." 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 THEY USED THE DEVICE FOR ANGIOGRAPHY. THE CATHETER WAS KINKED WHILE IT WAS SUBJECTED TO MANIPULATION INCLUDING AN APPLICATION OF TORQUE. IT SEEMED THAT THEY FURTHER ROTATED IT AS IT WAS. FRACTURE OCCURRED WHEN THEY WANTED TO PULL IT OUT. THE FRACTURED PIECE WAS SURGICALLY RETRIEVED. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS HARMED BUT NOT SERIOUSLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759380 RADIFOCUS GLIDECATH CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO TERUMO CORPORATION, ASHITAKA N/A 220331

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention