BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTITORQUE ANGIOGRAPHIC CATHETER

    MDR report key: 11200497 · Received January 20, 2021

    Report

    Report Number
    9681834-2020-00272
    Event Type
    Malfunction
    Date Received
    January 20, 2021
    Date of Event
    December 21, 2020
    Report Date
    January 20, 2021
    Product Code
    DQO
    PMA / PMN Number
    K082736
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    A CORRECTION HAS BEEN MADE IN SECTION D4; CATALOG #, IT WAS INITIALLY REPORTED TO BE RH-5JL4020 AND HAS BEEN UPDATED TO REFLECT THE CONFIRMED PRODUCT CODE: RH-5JL4020Z. BASED ON THE INVESTIGATION RESULTS, IT WAS LIKELY THAT AIR ENTERED THROUGH THE PINHOLE FOUND ON THE ACTUAL SAMPLE SURFACE. FROM THE STATE OF THE ACTUAL SAMPLE, IT WAS SPECULATED THAT, IN THE MANUFACTURING PROCESS, AN ANOMALY MIGHT HAVE OCCURRED IN THE INNER SURFACE DUE TO SOME FACTORS AND THIN-WALL PART WAS FORMED, AND AFTERWARD, WHEN THE ACTUAL SAMPLE WAS EXPOSED TO AN EXTERNAL LOAD, THE PINHOLE WAS MADE. IT WAS PRESUMED THAT THE ACTUAL SAMPLE WITH THE PINHOLE MAY HAVE BEEN OVERLOOKED IN THE SUBSEQUENT VISUAL INSPECTION. HOWEVER, WITH NO DEVICE RETURN THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION.

    Additional Manufacturer Narrative · 1

    IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. PMA/510(K)- K992051 K150232. A REVIEW OF THE DEVICE HISTORY RECORD AND SHIPPING INSPECTION RECORD OF THE INVOLVED PRODUCT CODE/LOT# COMBINATION WAS CONDUCTED WITH NO FINDINGS. THE ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED A PINHOLE AT APPROXIMATELY 900MM FROM THE DISTAL END. MAGNIFYING INSPECTION OF THE PINHOLE OF THE ACTUAL SAMPLE REVEALED: PINHOLE DIAMETER: APPROXIMATELY 0.11MM; ROUGHNESS; BULGE. ELECTRON MICROSCOPIC INSPECTION OF THE PINHOLE OF THE ACTUAL SAMPLE REVEALED: CREASE; IT HAD BEEN RUPTURED FROM THE INSIDE TO THE OUTSIDE; BULGE. X-RAY FLUOROSCOPIC INSPECTION OF THE PINHOLE OF THE ACTUAL SAMPLE REVEALED THE BLADE WIRE WAS NOT JUMBLED; IT HAD BEEN RUPTURED PERPENDICULARLY; NO ANOMALY SUCH AS A FOREIGN SUBSTANCE GETTING CAUGHT AROUND THE PINHOLE WAS FOUND; MULTIPLE DENTS WERE FOUND AROUND THE PINHOLE; THE PINHOLE AND DENTS HAD BEEN OCCURRED BETWEEN BLADE WIRES. USING THE CURRENT PRODUCT AS A COMPARISON TARGET, THE WALL THICKNESS (THE THINNEST PART) WAS CONFIRMED BY X-RAY FLUOROSCOPY AND REVEALED THE ACTUAL SAMPLE: APPROXIMATELY 0.12MM AND THE CURRENT PRODUCT: APPROXIMATELY 0.22MM. THE ACTUAL SAMPLE WAS CUT IN THE LONGITUDINAL DIRECTION, AND THE INNER SURFACE WAS CONFIRMED UNDER MAGNIFICATION. TWO DENTS WERE FOUND. AFTER CUTTING THE ACTUAL SAMPLE, THE INNER SURFACE WAS CONFIRMED WITH AN ELECTRON MICROSCOPE AND REVEALED: NO ANOMALY INCLUDING A SCRATCH WAS FOUND AROUND THE PINHOLE; NO ANOMALY INCLUDING A SCRATCH WAS FOUND AROUND THE DENT; THERE WAS A CRACK ON THE SURFACE OF THE DENT. MAGNIFYING INSPECTION OF THE NORMAL SECTION OF THE ACTUAL SAMPLE DID NOT FIND ANY ANOMALY INCLUDING A KINK OR SCRATCH. MAGNIFYING INSPECTION OF THE LUMEN (HUB PART AND DISTAL PART) OF THE ACTUAL SAMPLE DID NOT FIND ANY TRACES OF BLOCKAGE OF THE FLOW PATH. 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 · 1

    THE USER FACILITY REPORTED THE INVOLVED RADIFOCUS OPTITORQUE WAS USED DURING THE PROCEDURE. WHEN THEY ATTEMPTED TO PERFORM AN ANGIOGRAPHY, AIR GOT INTO THE CATHETER. THE PATIENT WAS NOT HARMED. THE PROCEDURE OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96669 OPTITORQUE ANGIOGRAPHIC CATHETER CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO NA 200212

    Patients

    Seq Age Sex Outcome Treatment
    1