BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETRACTA DETACHABLE EMBOLIZATION COIL

    MDR report key: 6304147 · Received February 6, 2017

    Report

    Report Number
    1820334-2017-00213
    Event Type
    Malfunction
    Date Received
    February 6, 2017
    Date of Event
    December 23, 2016
    Report Date
    December 23, 2016
    Manufacturer
    COOK INC
    Product Code
    KRD
    UDI-DI
    10827002341989
    PMA / PMN Number
    K123712
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION - THE DEVICE WAS NOT RETURNED TO ASSIST WITH THE INVESTIGATION. IF THE COMPLAINT DEVICE BECOMES AVAILABLE FOR INVESTIGATION, THE DEVICE WILL BE EVALUATED AND THE FILE WILL BE UPDATED AT THAT TIME. THE DEVICE WAS SHIPPED WITH INSTRUCTIONS FOR USE (IFU), WHICH PROVIDES THE WARNINGS, PRECAUTIONS, AND INSTRUCTIONS FOR USE. IN THE INSTRUCTIONS FOR USE SECTION, THE IFU STATES "IF THE COIL POSITION IS CORRECT, USE THE TORQUE DEVICE TO TURN THE DELIVERY WIRE COUNTERCLOCKWISE 8-10 TIMES, UNTIL COIL DETACHMENT CAN EITHER BE FELT OR VISUALIZED UNDER FLUOROSCOPY. IT IS RECOMMENDED THAT THE JUNCTION REMAIN JUST INSIDE THE TIP OF THE CATHETER." THE IFU IN THE COIL DELIVERY TECHNIQUE AND COIL SIZE SELECTION ALSO STATES "IN GENERAL, THE FIRST COIL SELECTED SHOULD HAVE A DIAMETER THAT IS 20% LARGER, OR 2 MM OVERSIZED, THAN THE VESSEL THAT IS BEING OCCLUDED." A COMPLAINT HISTORY SEARCH REVEALED THIS TO BE THE ONLY REPORTED COMPLAINT ASSOCIATED TO THE COMPLAINT LOT NUMBER 7130984. FOR THIS CASE, VERY LIMITED INFORMATION WAS AVAILABLE. NO ADDITIONAL EVALUATION OF THE DEVICE WAS PERFORMED SINCE THE DEVICE WAS NOT RETURNED, AND IMAGES WERE NOT PROVIDED. NO EVIDENCE WAS FOUND INDICATING THAT THE DEVICE WAS MANUFACTURED OUTSIDE OF COOK INC. SPECIFICATIONS. BASED ON THE DESCRIPTION OF EVENT, IT IS LIKELY THAT THE EVENT WAS CAUSED BY THE USER TECHNIQUE, HOWEVER, AT THIS TIME THERE IS NO OBJECTIVE EVIDENCE TO DETERMINE IF THIS COMPLAINT WAS CAUSED BY A PROCEDURAL OR DEVICE RELATED CIRCUMSTANCE. THUS THE ROOT CAUSE OF THIS EVENT CANNOT BE DETERMINED. NEVERTHELESS, THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED OF THIS INCIDENT. NO RISK REDUCTION MEASURES ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    DURING A PELVIC CONGESTION EMBOLIZATION PROCEDURE, THE PHYSICIAN HAD INSERTED THE RETRACTA DETACHABLE EMBOLIZATION COIL, BUT ENCOUNTERED DIFFICULTY TO DEPLOY. IT WAS REPORTED THAT THE PHYSICIAN HAD TO ROTATE THE DEPLOYMENT WIRE ABOUT 30 TIMES TO GET THE COIL TO DEPLOY (1820334-2017-00213). A SECOND DEVICE OF A LARGER SIZE WAS REPORTED TO HAVE BEEN USED DURING THE SAME PROCEDURE. THE ATTENDING PHYSICIAN ALSO EXPERIENCED DIFFICULTY DEPLOYING THIS DEVICE. THE DEVICE WIRE BROKE WHILE THE ATTENDING WAS PERFORMING ADDITIONAL MANIPULATION TO DEPLOY THE COIL (1820334-2017-00040). THE PHYSICIAN OBTAINED A COMPETITORS' DEVICE AND SUCCESSFULLY COMPLETED THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86303 RETRACTA DETACHABLE EMBOLIZATION COIL KRD DEVICE, EMBOLIZATION, VASCULAR KRD COOK INC N/A 10827002341989

    Patients

    Seq Age Sex Outcome Treatment
    1