BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPIDER FX

    MDR report key: 10342898 · Received July 30, 2020

    Report

    Report Number
    2183870-2020-00236
    Event Type
    Injury
    Date Received
    July 30, 2020
    Date of Event
    May 23, 2020
    Report Date
    September 21, 2020
    Manufacturer
    COVIDIEN
    Product Code
    NTE
    UDI-DI
    00821684068328
    PMA / PMN Number
    K111010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT ANALYSIS: A SPIDER FX AND SNARE DEVICE WERE RETURNED FOR ANALYSIS INSIDE A PREVIOUSLY OPENED SPIDER FX BOX AND POUCH WHICH INDICATED LOT A791850. NO OTHER ANCILLARY DEVICES WERE INCLUDED. THE SPIDER FX WAS RETURNED WITH THE DELIVERY CATHETER FRACTURED APART INTO TWO SEGMENTS. THE DISTAL SEGMENT WAS APPROXIMATELY 22CM IN LENGTH AND SHOWED THE SNARE DEVICE WAS CAPTURED AT APPROXIMATELY 21CM FROM THE DISTAL TIP. THE FRACTURE FACE WAS RADIAL AND SHOWED SIGNS OF STRETCHING. THE LOCATION OF THE FRACTURE WAS AT THE PRIMARY WIRE EXIT PORT. THE SECOND SEGMENT INSPECTED FOUND THE CAPTURE WIRE WAS LOADED AND THE FILTER ASSEMBLY WAS IDENTIFIED INSIDE THE CLEAR SEGMENT OF THE CATHETER. THE FRACTURE FACE WAS RADIAL AND SHOWED SIGNS OF STRETCHING. THE LOCATION OF THE FRACTURE WAS AT THE PRIMARY WIRE EXIT PORT. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A SPIDER FX DEVICE WAS RETURNED TO THE LAB, WHERE THE GREEN DELIVERY CATHETER APPEARS TO HAVE BROKEN IN VIVO AT THE PRIMARY EXIT PORT. IT SEEMS THAT IT WAS SNARED BY A COMPETITORS SNARE TO BE RECOVERED. THE SPIDER FX FILTER WAS LOCATED IN THE TRANSPARENT SECTION OF THE DELIVERY CATHETER. ALL COMPONENTS ARE ACCOUNTED FOR. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809818 SPIDER FX CATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE NTE COVIDIEN SPD2-US-040-320 A791850 00821684068328

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Required Intervention