BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLIDESHEATH

    MDR report key: 15996351 · Received December 16, 2022

    Report

    Report Number
    9681834-2022-00256
    Event Type
    Injury
    Date Received
    December 16, 2022
    Date of Event
    October 13, 2022
    Report Date
    December 16, 2022
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DYB
    PMA / PMN Number
    K033681
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT IDENTIFIER: REQUESTED, NOT PROVIDED. DATE OF BIRTH: REQUESTED, NOT PROVIDED. ETHNICITY: REQUESTED, NOT PROVIDED. RACE: REQUESTED, NOT PROVIDED. CATALOG NUMBER: RS*B60N10MR5, RS*B70N10MR5 AND RS*B80N10MR5 (POTENTIAL PRODUCT CODES). LOT NUMBER: UNKNOWN. EXPIRATION DATE: UNKNOWN DUE TO UNKNOWN LOT NUMBER. UDI - N/A AS THIS PRODUCT CODE IS NOT EXPORTED TO THE US MARKET. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. CONCOMITENT MEDICAL PRODUCTS: SUPREME 6F FIXED HEXAPOLE DIAGNOSTIC CATHETER 5-5-5-175-175 (ABBOTT), HEMO INTRO 8.5F 62CM SL1032GW (ABBOTT), BRK-1 TRANSSEPTAL NEEDLE (XS SERIES) 71CM LENGTH (ABBOTT), BI DIR 7FR DEFL CS CATH NON- (JOHNSON & JOHNSON), CARTO3 REF PATCH (JOHNSON & JOHNSON), THMCL SMRTTCH BI NAV TC D-F C3 (JOHNSON & JOHNSON), LASSO 2515 NAV ECO VARIABLE CATHETER D TYPE 10 (JOHNSON & JOHNSON), SMARTABLATE IRRIGATION TUBING SET (JOHNSON & JOHNSON), S-CATH M ESOPHAGEAL TEMPERATURE PROBE 10FR OD 65CM (LIFE SYSTEMS MEDICAL) PMA/510(K): K033681, K062858, K082644 DEVICE MANUFACTURE DATE: UNKNOWN DUE TO UNKNOWN LOT NUMBER. THE ACTUAL DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION OF THE ACTUAL DEVICE WAS UNABLE TO BE CONDUCTED. THE FOLLOWING INVESTIGATION WAS CONDUCTED ON THE ABOVE-MENTIONED THREE PRODUCT CODES AS A POSSIBLE SOURCE OF THE FOREIGN BODY: 1.1 IT WAS NOT POSSIBLE TO IDENTIFY WHICH OF THE THREE PRODUCT CODES THE FOREIGN BODY CAME FROM. 1.2 FROM THE PROVIDED PICTURE OF THE FOREIGN BODY, THE SHAPE OF THE BROKEN PART CANNOT BE SPECIFIED. REVIEW OF THE MANUFACTURING HISTORY RECORD AND THE PRODUCT INSPECTION RECORD COULD NOT BE CARRIED OUT SINCE THE INVOLVED LOT NUMBER WAS UNKNOWN. A SEARCH OF THE QUALITY INFORMATION OF THE PAST THREE YEARS REGARDING THE ABOVE-MENTIONED THREE PRODUCT CODES FOUND NO SIMILAR EVENTS IN THEM. ACCORDING TO THE INVESTIGATION RESULT, NO ANOMALY WAS FOUND IN THE MANUFACTURING RELATED RECORDS. SINCE THE ACTUAL SAMPLE WAS NOT RETURNED AND CONDITION OF IT COULD NOT BE CONFIRMED, THE CAUSE OF OCCURRENCE COULD NOT BE CLARIFIED. RELEVANT IFU (INSTRUCTIONS FOR USE) REFERENCE: "RELEVANT IFU REFERENCE: PRECAUTIONS 16ST DOT: DO NOT SCRATCH THE SHEATH WITH NEEDLE POINT, CUTTING TOOL, OR OTHER EDGED TOOLS." (B)(4).

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE PATIENT WAS READMITTED TWO WEEKS POST ABLATION WITH PERICARDIAL EFFUSION. FOREIGN BODY WAS FOUND IN THE RIGHT ATRIUM CONSISTENT WITH PART OF FEMORAL SHEATH. THIS WAS REMOVED AND THE PATIENT WAS TREATED WITH ANTIBIOTICS AND DISCHARGED FIT AND WELL. FOUR TERUMO SHEATHS (6,7 AND 8FR) WERE USED; HOWEVER, THEY WERE UNABLE TO IDENTIFY WHICH SHEATH WAS USED AS THE SAMPLE PIECE WAS DISCARDED. MEDICAL/SURGICAL INTERVENTION WAS PERFORMED LATER TO REMOVE THE FOREIGN BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1392848 GLIDESHEATH INTRODUCER, CATHETER DYB TERUMO CORPORATION, ASHITAKA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Male Required Intervention| O