BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO RADIFOCUS GUIDE WIRE

    MDR report key: 21340054 · Received February 7, 2025

    Report

    Report Number
    9681835-2025-00007
    Event Type
    Malfunction
    Date Received
    February 7, 2025
    Date of Event
    December 27, 2024
    Report Date
    February 7, 2025
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K863138
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS FOLLOW-UP NO. 1 TO CORRECT THE MFR NUMBER 9681835-2025-00007, WHICH WAS USED IN ERROR. THE ORIGINALLY SUBMITTED MFR NUMBER (9681835-2025-00007) WAS IDENTIFIED AS A DUPLICATE AND IS INCORRECT. TO PREVENT CONFUSION AND MAINTAIN PROPER SEQUENCING OF REGISTRATION NUMBERS, THIS MFR NUMBER WILL NO LONGER BE REFERENCED IN FUTURE REPORTS. A CORRECTION REPORT HAS BEEN SUBMITTED UNDER MFR NUMBER 9681834-2025-00007, AND ALL SUBSEQUENT REPORTS WILL REFERENCE THE CORRECT MFR NUMBER.

    Additional Manufacturer Narrative · 0

    A1: PATIENT IDENTIFIER: REQUESTED, NOT PROVIDED A2: AGE & DATE OF BIRTH: REQUESTED, NOT PROVIDED A3A: SEX: REQUESTED, NOT PROVIDED A3B: GENDER: REQUESTED, NOT PROVIDED A4: WEIGHT: REQUESTED, NOT PROVIDED A5: ETHNICITY: REQUESTED, NOT PROVIDED A6: RACE: REQUESTED, NOT PROVIDED D4: LOT #: REQUESTED, UNKNOWN D4: EXPIRATION DATE: UNKNOWN, AS THE INVOLVED PRODUCT LOT # WAS UNKNOWN D4: UDI: N/A AS THIS PRODUCT CODE IS NOT EXPORTED TO THE US MARKET. D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED G4: 510K: K863138,K926214 H4: DEVICE MANUFACTURE DATE: UNKNOWN, AS THE INVOLVED PRODUCT LOT # WAS UNKNOWN. THE ACTUAL SAMPLE AND THE COMBINED DEVICE WERE RETURNED. APPEARANCE INSPECTION OF THE ACTUAL SAMPLE (DIGITAL MICROSCOPE) TRANSPARENT SUBSTANCES HAD WOVEN AROUND THE ACTUAL SAMPLE, SPECIFICALLY FROM APPROXIMATELY. 330 MM TO 399 MM AND FROM 563 MM TO 670 MM FROM THE DISTAL END. THERE WERE NO ANOMALIES IN OTHER AREAS, SUCH AS SCRATCHES. THE COMBINED TEST (UNAIDED EYE) TRIED TO INSERT THE COMBINED DEVICE FROM THE NEAR END OF THE ACTUAL SAMPLE. THE INSERTION BECAME IMPOSSIBLE AT APPROX. 1085 MM FROM THE DISTAL END OF THE GUIDEWIRE. THE SLIDABILITY OF THE ACTUAL SAMPLE WAS EVALUATED USING MANUAL TACTILE ASSESSMENT, AND NO ANOMALIES WERE DETECTED. FT-IR* ANALYSIS THE TRANSPARENT SUBSTANCE WAS SUBJECTED TO A QUALITATIVE ANALYSIS USING FT-IR. THE SPECTRUM OBTAINED WAS LIKE THAT OF POLYETHYLENE. *FT-IR (FOURIER TRANSFORM INFRARED SPECTROSCOPY): AN ANALYSIS METHOD USED TO IDENTIFY THE MOLECULAR STRUCTURE OF AN OBJECT BY ANALYZING THE SPECTRUM OBTAINED FROM INFRARED RADIATION APPLIED TO THE MEASUREMENT TARGET. SINCE THE WAVELENGTH OF THE INFRARED RADIATION ABSORBED IS NEARLY DISTINCTIVE FOR EACH OBJECT, IT IS POSSIBLE TO CONDUCT QUALITATIVE ANALYSIS OF THE OBJECT BY COMPARING IT WITH A STANDARD SAMPLE OF INFRARED ABSORPTION SPECTRUM. THE DIMENSIONS OF THE MAIN BODY (THICKNESS GAUGE) AND THE OUTER DIAMETER (UNDAMAGED SECTION) MET THE FACTORY'S STANDARDS. NO ANOMALY WAS OBSERVED. DUE TO THE UNKNOWN LOT NUMBER, A HISTORICAL INVESTIGATION OF THE INVOLVED PRODUCT CODE AND LOT COULD NOT BE PERFORMED. HOWEVER, THERE HAVE BEEN NO REPORTED INCIDENTS ATTRIBUTABLE TO THE MANUFACTURING PROCESS FOR THIS PRODUCT IN THE PAST TWO YEARS. INVESTIGATION OF THE MANUFACTURING PROCESS: AFTER VERIFICATION, IT HAS BEEN CONFIRMED THAT THERE IS NO PROCESS IN WHICH POLYETHYLENE COULD COME INTO CONTACT WITH THE PRODUCTS IN A MANNER SIMILAR TO WHAT WAS OBSERVED IN THE ACTUAL SAMPLE. IN THE EVENT THAT ANY FOREIGN SUBSTANCE, SUCH AS THE ONE FOUND ON THE ACTUAL SAMPLE, IS ATTACHED TO THE PRODUCTS, IT CAN BE DETECTED THROUGH THE IN-PROCESS INSPECTIONS, WHICH INCLUDE MANUAL TACTILE AND VISUAL INSPECTIONS. SINCE THE LOT INVOLVED IN THIS ISSUE WAS UNKNOWN, THE REVIEW OF MANUFACTURING RECORDS AND SHIPPING INSPECTION RECORDS COULD NOT BE PERFORMED. THE INVESTIGATION RESULTS SUGGESTED THAT THE TRANSPARENT FOREIGN SUBSTANCE WAS POLYETHYLENE. HOWEVER, IT WAS CONSIDERED EXTREMELY UNLIKELY THAT POLYETHYLENE WOULD HAVE BEEN WRAPPED AROUND THIS PRODUCT BEFORE THE ACTUAL SAMPLE WAS SHIPPED FROM THE FACTORY. SINCE NO ANOMALY WAS FOUND IN THE DIMENSIONS AND THE SLIDABILITY, THE ACTUAL SAMPLE WAS THOUGHT TO BE A NORMAL PRODUCT. THE SHAPE OF THE POLYURETHANE INDICATED THAT IT COULD POTENTIALLY BE THE INNER SHAFT OF THE COMBINED DEVICE. HOWEVER, DUE TO THE LACK OF TECHNICAL INFORMATION IN OUR POSSESSION, THIS COULD NOT BE CONFIRMED. IN ADDITION, DUE TO THE UNCLEAR DETAILS OF THE PROCEDURES, IT WAS NOT POSSIBLE TO CLARIFY THE FACTORS THAT CAUSED THE COMBINED DEVICE TO BE STUCK TO THE ACTUAL SAMPLE. RELEVANT IFU REFERENCE: DIRECTIONS FOR USE: FILL THE HOLDER WITH HEPARINIZED PHYSIOLOGICAL SALINE SOLUTION THROUGH THE HUB OF THE HOLDER USING A SYRINGE. TERUMO MEDICAL PRODUCTS (TMC) (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 AFTER CROSSING A LESION WITH THE GUIDEWIRE, THEY ATTEMPTED TO INSERT THE ANGIOSCULPT DEVICE FROM PHILIPS, BUT IT GOT STUCK AND COULD NOT BE INSERTED. UPON REMOVAL, THEY DISCOVERED A WHITE SUBSTANCE ATTACHED TO THE GUIDEWIRE. THEY ATTEMPTED TO FLUSH AND RETRY THE INSERTION, BUT IT STILL COULDN'T BE INSERTED. THEY RESOLVED THE ISSUE BY REPLACING THE GUIDEWIRE WITH A NEW ONE. THE EVENT OCCURRED INTRA-OPERATIVELY. THE REPORTED INCIDENT DID NOT RESULT IN PATIENT INJURY OR NECESSITATE MEDICAL OR SURGICAL INTERVENTION. THE FINAL PATIENT IMPACT WAS NO HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835644 TERUMO RADIFOCUS GUIDE WIRE WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown