BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETRACTA DETACHABLE EMBOLIZATION COIL

    MDR report key: 6263096 · Received January 19, 2017

    Report

    Report Number
    1820334-2017-00040
    Event Type
    Malfunction
    Date Received
    January 19, 2017
    Date of Event
    December 23, 2016
    Report Date
    December 23, 2016
    Manufacturer
    COOK INC
    Product Code
    KRD
    UDI-DI
    10827002342009
    PMA / PMN Number
    K123712
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ***CORRECTED INFORMATION*** EVALUATION: AN INCOMPLETE DEVICE WAS RETURNED FOR EVALUATION. AS INDICATED IN THE DEVICE FAILURE ANALYSIS FORM, IN GENERAL, THE RETURNED DEVICE WAS DESCRIBED AS ONE USED DELIVERY WIRE RETURNED IN A DAMAGED CONDITION. THE EMBOLIZATION COIL WAS NOT RETURNED. EXAMINATION FOUND THE DISTAL SOLDER TO BE MISSING AND THE DELIVERY COIL WAS ELONGATED AND UNRAVELED. THE EXACT LENGTH MAY BE UNDETERMINABLE DUE TO PART OF THE DELIVERY WIRE MISSING. SOLDERS CONNECTIONS HAD GOOD AND EVEN SOLDER AND THE SOLDERS WERE SECURE. 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 7113032. THE RETURNED DEVICE SHOWED THAT THE SOLDERS CONNECTIONS HAD GOOD AND EVEN SOLDER AND THE SOLDERS WERE SECURE AND IT ALSO SHOWS THAT DISTAL SOLDER WAS MISSING AND THE DELIVERY COIL WAS ELONGATED AND UNRAVELED. THE DELIVERY WIRE WAS ALSO MISSING. THIS IS CONSISTENT WITH THE CLINICIAN MANIPULATING THE WIRE TOO MUCH AND BREAKING THE SOLDER, THAT IN TURNED CAUSED THE WIRE TO SEPARATE. FOR THIS CASE, AN INCOMPLETE DEVICE WAS RETURNED, WHERE THE EMBOLIZATION COIL AND THE DISTAL SOLDER WERE MISSING. REVIEW OF THE MANUFACTURING, INSPECTING AND INSTRUCTIONS FOR USE WERE REVIEWED AS WELL AS THE HISTORY RECORD AND COMPLAINT HISTORY FOR THE DEVICE. NO EVIDENCE WAS FOUND INDICATING THAT THE DEVICE WAS MANUFACTURED OUTSIDE OF SPECIFICATIONS. BASED ON THE INFORMATION PROVIDED IN THE DESCRIPTION OF EVENTS INDICATING THAT THE PHYSICIAN HEAVILY MANIPULATED THE DEVICE AND WHAT WAS OBSERVED IN THE RETURNED SAMPLE, THE MOST PROBABLE CAUSE IS USER TECHNIQUE. ROOT CAUSE WILL BE DOCUMENTED AS PRODUCT USE / HANDLING RELATED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED OF THIS INCIDENT. NO RISK REDUCTION MEASURES ARE REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION.

    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO THE DIVISION SALES MANAGER THAT DIFFICULTY WAS EXPERIENCED WITH A RETRACTA DETACHABLE EMBOLIZATION COIL DURING A PELVIC CONGESTION EMBOLIZATION PROCEDURE. THE ATTENDING PHYSICIAN EXPERIENCED DIFFICULTY DEPLOYING THE DEVICE. THE DEVICE WIRE BROKE WHILE THE ATTENDING WAS PERFORMING ADDITIONAL MANIPULATION TO DEPLOY THE COIL. THE PHYSICIAN OBTAINED A COMPETITORS' DEVICE AND SUCCESSFULLY COMPLETED THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO FURTHER EVENT OR PATIENT DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45879 RETRACTA DETACHABLE EMBOLIZATION COIL KRD DEVICE, EMBOLIZATION, VASCULAR KRD COOK INC N/A 10827002342009

    Patients

    Seq Age Sex Outcome Treatment
    1