BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM

    MDR report key: 6643006 · Received June 15, 2017

    Report

    Report Number
    3008264254-2017-00079
    Event Type
    Malfunction
    Date Received
    June 15, 2017
    Date of Event
    July 7, 2015
    Report Date
    May 29, 2017
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS FOLLOW-UP REPORT WITH ASSOCIATED MFR# 3008264254-2017-00079. THIS SUBMISSION IS RELATED TO A LITERATURE ARTICLE DISCOVERED IN AN EFFORT TO SUPPORT THE CER SUBMISSION PROCESS, AS SUCH, THE ASSOCIATED TIME FRAME OF EVENT DATES INCLUDES BUT IS NOT LIMITED TO 20 YEARS. THESE ARTICLES ARE BEING REVIEWED ON A MONTHLY BASIS FOR SAFETY SIGNALS AND WILL BE FOLLOWED BY MONTHLY TRENDING ASSESSMENTS AS WELL AS PMS REVIEWS.

    Additional Manufacturer Narrative · 1

    THIS IS INITIAL/FINAL MDR BEING SUBMITTED WITH ASSOCIATED MFR# 3008264254-2017-00079. BRAND NAME: TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM OR TRUFILL PUSHABLE COILS AND TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM. ADDITIONAL PROCODE: KRD. CATALOG# 640CF3509 OR 637MF3509. UDI UNAVAILABLE; CATALOG#/LOT UNKNOWN. K093973 OR K123560. BASED ON THE INFORMATION, THE EVENT COULD NOT BE CONFIRMED. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; HOWEVER A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    IN THE LITERATURE ARTICLE ¿INTRAVASCULAR ULTRASOUND SHOWS THE DETAILED APPEARANCE OF AN UNRAVELED COIL IDENTIFIED ON ECHOCARDIOGRAPHY¿ BY TATSUYA OONISHI, KAZUYA TERADA, TAKAYUKI OKU, KEISUKE FUKUDOME, YUICHI MIYAGI, AKIRA OHTA, PUBLISHED J ECHOCARDIOGR (2015) 13:107¿109 DOI 10.1007/S12574-015-0251-7, THE AUTHORS PRESENT A CASE WHERE THEY ASSESS AN UNRAVELED COIL WITH ECHOCARDIOGRAPHY AND INTRAVASCULAR ULTRASOUND. A (B)(6) BOY (B)(6) DIAGNOSED WITH SINGLE RIGHT VENTRICLE WAS ADMITTED FOR CATHETERIZATION 17 MONTHS AFTER COIL EMBOLIZATION OF COLLATERAL ARTERIES USING TRUFILL DCS ORBIT (3.5 MM/9 CM) (CAT# 640CF3509 AND/OR 637MF3509 LOT# UNKNOWN) AND THE FONTAN OPERATION. ECHOCARDIOGRAPHY SHOWED A BRIGHT LINEAR SHADOW IN THE ABDOMINAL AORTA, WITH THE TAIL EXTENDING INTO THE CELIAC ARTERY. ENHANCED COMPUTED TOMOGRAPHY AND FLUOROSCOPY REVEALED THAT THE COIL HAD UNRAVELED FROM THE COLLATERAL ARTERY TO THE CELIAC BRANCH ARTERY. BECAUSE LEFT HEART CATHETERIZATION USING A 4-FR PIGTAIL CATHETER WAS PERFORMED SAFELY, WE JUDGED IT APPROPRIATE TO USE 3.5-FR INTRAVASCULAR ULTRASOUND (IVUS). AFTER INSERTING A 0.018 IN. GUIDEWIRE INTO THE RIGHT SUBCLAVIAN ARTERY, IVUS WAS DEPLOYED AND PULLED CAREFULLY. IVUS SHOWED THE APPEARANCE OF THE UNRAVELED COIL (UC), WHICH DID NOT ADHERE TO THE INNER WALL BUT FLOATED IN THE AORTA, AND THERE WAS NO THROMBUS AROUND IT. RETRIEVAL OF THE COIL WAS DEEMED UNNECESSARY AND IMPOSSIBLE BASED ON THE IMAGING FINDINGS. AT THE TIME OF COMPLAINT ENTRY, NO DEVICE SPECIFIC INFORMATION, I.E. CATALOGUE/LOT NUMBER, IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426282 TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM NEUROVASCULAR EMBOLIZATION DEVICE HCG CODMAN AND SHURTLEFF, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR 4-FR PIGTAIL CATHETER, 0.018 IN. GUIDEWIRE