BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGREAT LAMBDA

    MDR report key: 21478475 · Received February 27, 2025

    Report

    Report Number
    3009500972-2025-00005
    Event Type
    Malfunction
    Date Received
    February 27, 2025
    Date of Event
    January 29, 2025
    Report Date
    February 27, 2025
    Manufacturer
    TERUMO CLINICAL SUPPLY CO., LTD.
    Product Code
    DQO
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A3B: GENDER: N/A. D2: PRODUCT CODE: DQO, KRA. D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. 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. TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER), REGISTRATION NO. 2243441, IS SUBMITTING THIS REPORT ON BEHALF OF TERUMO CLINICAL SUPPLY CO., LTD. (MANUFACTURER), REGISTRATION NO. 3009500972.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SENT AS FOLLOW-UP NO. 1 TO CORRECT SECTION B4 ON THE INITIAL REPORT, AS CONGENITAL ANOMALY/BIRTH DEFECT WAS INADVERTENTLY CHECKED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SENT AS FOLLOW-UP NO. 2 TO UPDATE SECTION H3 AND TO PROVIDE THE COMPLETED INVESTIGATION RESULTS. ONLY THE MICROCATHETER (HEREINAFTER REFERRED TO AS THE INVOLVED DEVICE) WAS RETURNED FOR EVALUATION. VISUAL INSPECTION OF THE INVOLVED DEVICE REVEALED STEP-LIKE DEFORMATIONS LOCATED APPROXIMATELY 6.2 CM AND 6.7 CM FROM THE DISTAL TIP. NO PERFORATION WAS OBSERVED AT THE 6.2 CM LOCATION; HOWEVER, A PERFORATION WAS IDENTIFIED AT APPROXIMATELY 6.7 CM FROM THE DISTAL TIP. INNER AND OUTER DIAMETERS OF THE INVOLVED DEVICE WERE MEASURED TO ASSESS FOR ABNORMALITIES THAT MAY CONTRIBUTE TO TUBE DEFORMATION, SUCH AS INSUFFICIENT RESIN THICKNESS. THE OUTER DIAMETERS AT APPROXIMATELY 6.2 CM AND 6.7 CM FROM THE DISTAL TIP WERE FOUND TO BE OUTSIDE OF THE ESTABLISHED STANDARD VALUES. MEASUREMENTS OF THE INNER AND OUTER DIAMETERS AT BOTH THE DISTAL AND PROXIMAL ENDS OF THE DEVICE WERE WITHIN STANDARD VALUES, AND NO ABNORMALITIES WERE FOUND. SIMULATION TEST WAS CONDUCTED TO EVALUATE THE DEFORMATIONS AND PERFORATIONS OF THE CATHETER USING THE FOLLOWING SAMPLES: MICROCATHETER (CC-M1911D, LOT NUMBER 211202020) & GUIDEWIRE (RG-GA1618S, LOT NUMBER 210309) GUIDEWIRE WAS INSERTED INTO THE MICROCATHETER. THE MICROCATHETER WITH THE GUIDEWIRE INSERTED WAS PASSED THROUGH A THREE-WAY STOPCOCK, AND THE COCK WAS ROTATED. · WHEN THE COCK WAS TILTED AT AN ANGLE OF APPROXIMATELY 20°, TWO STEP-LIKE DEFORMATIONS OCCURRED. NO PERFORATIONS WERE OBSERVED. · WHEN THE COCK WAS TILTED AT AN ANGLE OF APPROXIMATELY 45°, TWO STEP-LIKE DEFORMATIONS OCCURRED. THE DEFORMATION PART HAD THE OUTER LAYER MATERIAL STRETCHED, AND SOME PERFORATIONS WERE OBSERVED. · WHEN THE COCK WAS TILTED AT AN ANGLE OF APPROXIMATELY 90°, TWO STEP-LIKE DEFORMATIONS OCCURRED. THE DEFORMATION PART HAD THE OUTER LAYER MATERIAL STRETCHED FURTHER, AND SOME PERFORATIONS WERE OBSERVED. FOR THE PROGREAT DEVICE, VISUAL INSPECTIONS AND DIMENSIONAL MEASUREMENTS ARE PERFORMED BY SAMPLING EACH PRODUCTION LOT. ADDITIONALLY, VISUAL INSPECTIONS ARE CONDUCTED ON ALL UNITS PRIOR TO THE HOLDER ASSEMBLY STAGE IN THE MANUFACTURING PROCESS. A REVIEW OF THE DEVICE HISTORY RECORDS FOR LOT NUMBER 240600140 INDICATED NO ABNORMALITIES IN THE RESULTS OF THESE INSPECTIONS. NO CONDITIONS WERE IDENTIFIED THAT COULD CONTRIBUTE TO CATHETER DEFORMATION OR PERFORATION. WHEN OBSERVING THE APPEARANCE OF THE INVOLVED DEVICE, STEP-LIKE DEFORMATIONS WERE OBSERVED AT 6.2 CM AND 6.7 CM FROM THE DISTAL TIP. IN THE STEP-LIKE DEFORMATION PARTS, NO PERFORATION WAS FOUND AT 6.2 CM FROM THE DISTAL TIP, BUT PERFORATION WAS FOUND AT 6.7 CM FROM THE DISTAL TIP. AS A RESULT OF DIMENSION MEASUREMENT, THE OUTER DIAMETERS AT THE POINTS OF 6.2 CM AND 6.7 CM FROM THE DISTAL TIP OF THE INVOLVED DEVICE WERE OUTSIDE OF OUR STANDARD VALUES. IN ADDITION, THE INNER AND OUTER DIAMETERS OF DISTAL AND PROXIMAL PARTS OF THE INVOLVED DEVICE WERE WITHIN OUR STANDARD VALUES, AND NO ABNORMALITIES WERE FOUND. THE RESULTS OF THE SIMULATION TEST ARE AS FOLLOWS: · WHEN THE COCK WAS TILTED AT AN ANGLE OF APPROXIMATELY 20°, TWO STEP-LIKE DEFORMATIONS OCCURRED. NO PERFORATIONS WERE OBSERVED. · WHEN THE COCK WAS TILTED AT AN ANGLE OF APPROXIMATELY 45°, TWO STEP-LIKE DEFORMATIONS OCCURRED. THE DEFORMATION PART HAD THE OUTER LAYER MATERIAL STRETCHED; SOME PERFORATIONS WERE OBSERVED. · WHEN THE COCK WAS TILTED AT AN ANGLE OF APPROXIMATELY 90°, TWO STEP-LIKE DEFORMATIONS OCCURRED. THE DEFORMATION PART HAD THE OUTER LAYER MATERIAL STRETCHED FURTHER; SOME PERFORATIONS WERE OBSERVED. AS A RESULT OF REVIEWING DEVICE HISTORY RECORDS, THERE WERE NO ABNORMALITIES THAT COULD CAUSE THE CATHETER DEFORMATIONS AND PERFORATIONS. FROM THE ABOVE RESULTS, IT WAS CONSIDERED THAT THE CATHETER DEFORMATION AND PERFORATION THAT OCCURRED IN THE INVOLVED DEVICE MAY HAVE OCCURRED DUE TO THE OPERATION OF THE STOPCOCK WITH THE GUIDEWIRE IN PLACE. IN ADDITION, SINCE NO ABNORMALITIES WERE FOUND IN THE MANUFACTURING RECORDS, IT WAS CONSIDERED THAT THE CATHETER DEFORMATION AND PERFORATION THAT OCCURRED IN THE INVOLVED DEVICE MAY HAVE OCCURRED DURING USE AFTER SHIPMENT FROM OUR COMPANY.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT WHEN AN ATTEMPT WAS MADE TO EMBOLIZE THE TARGET BLOOD VESSEL USING THE INVOLVED PRODUCT, A HOLE WAS FOUND NEAR THE CATHETER'S TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616742 PROGREAT LAMBDA MICRO CATHETER SYSTEM DQO TERUMO CLINICAL SUPPLY CO., LTD. N/A 240600140

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Congenital Anomaly