BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLIDESHEATH

    MDR report key: 10926544 · Received December 1, 2020

    Report

    Report Number
    9681834-2020-00236
    Event Type
    Malfunction
    Date Received
    December 1, 2020
    Date of Event
    November 5, 2020
    Report Date
    December 1, 2020
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DYB
    PMA / PMN Number
    K033681
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. PMA/510(K)- K062858, K082644. (B)(4). TWELVE UNOPENED SAMPLE OF THE INVOLVED PRODUCT CODE/LOT# WERE RETURNED OR EVALUATION. VISUAL INSPECTION REVEALED THE ABSENCE OF FOREIGN SUBSTANCE INCLUDING HAIR INSIDE THE PACKAGES. NO RIP OR NO OTHER DAMAGE WAS OBSERVED IN THE PACKAGE FILM OR IN THE PACKAGE CARD. MAGNIFYING INSPECTION CONFIRMED THAT ALL THE SAMPLES WERE SECURELY SEALED AND NO ANOMALY SUCH AS A GAP IN THE SEAL WAS FOUND. A REVIEW OF THE DEVICE HISTORY RECORD AND SHIPPING INSPECTION RECORD OF THE INVOLVED PRODUCT CODE/LOT# COMBINATION WAS CONDUCTED WITH NO FINDINGS. BASED ON THE PROVIDED INFORMATION AND INVESTIGATION RESULTS, THERE IS NO DEFINITIVE EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. WITH NO RETURN OF THE ACTUAL SAMPLE, THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE INVOLVED RADIFOCUS INTRODUCER LL H WAS USED PRE-TREATMENT. AFTER AN IK KIT WAS OPENED ON THE SHELF ON WHICH IT HAD BEEN STORED, THE OPERATOR TOOK OUT THE DEVICE, AND THEN FOUND HAIR ADHERED TO THE VALVE BEFORE USING IT IN THE PATIENT. IT WAS CHANGED OUT WITH ANOTHER KIT OF THE SAME LOT. THE PROCEDURE WAS CONTINUED. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1395774 GLIDESHEATH INTRODUCER, CATHETER DYB TERUMO CORPORATION, ASHITAKA NA 200416

    Patients

    Seq Age Sex Outcome Treatment
    1