BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPIDER FX

    MDR report key: 18543783 · Received January 19, 2024

    Report

    Report Number
    2183870-2024-00019
    Event Type
    Injury
    Date Received
    January 19, 2024
    Date of Event
    January 9, 2024
    Report Date
    April 8, 2024
    Manufacturer
    COVIDIEN
    Product Code
    NTE
    UDI-DI
    00821684068342
    PMA / PMN Number
    K063204
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 0

    PRODUCT ANALYSIS VISUAL INSPECTION: THE DEVICE RETURNED WITH THE FILTER BASKET FULL, AND PART OF A STENT CAUGHT AROUND THE FILTER BASKET AND THE FILTER BASKET WAS DETACHED FROM THE CAPTURE WIRE AT THE PROXIMAL MARKER BAND A BEND WAS OBSERVED ON THE DISTAL FLOPPY TIP. A KINK WAS OBSERVED TO THE PROXIMAL MARKER BAND DAMAGE/FLATTENING WAS OBSERVED TO THE MARKER BAND ON THE GREEN DELIVERY CATHETER DAMAGE WAS OBSERVED TO THE GREEN DELIVERY CATHETER AND THE GREEN DELIVERY CATHETER TIP MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A SPIDER FX TO TREAT A CALCIFIED LESION IN THE RIGHT MID POPLITEAL ARTERY. DEGREE OF TORTUOSITY WAS MODERATE. DEGREE OF CALCIFICATION WAS SEVERE. A 6FR FORTRESS WAS USED. A 014 NITREX N143001 WAS USED. THE VESSEL WAS NOT PRE-DILATED. THE VESSEL WAS NOT POST-DILATED. IFU WAS FOLLOWED. THERE WAS ISSUE LOADING INTO THE DELIVERY CATHETER. SUPPLIED RECOVERY CATHETER WAS USED. THERE WAS DIFFICULTIES DURING PLACEMENT OF CATHETER. THERE WAS RESISTANCE. THE TIP DETACHED. CATHETER WAS ADVANCED PER PHYSICIAN AND GOT HUNG UP WHEN REPOSITIONING, THE RETRIEVAL CATHETER GOT STUCK AND TIP BROKE OFF. PHYSICIAN WAS ABLE TO SNARE. TIP DETACHMENT DID NOT RESULT IN INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1123056 SPIDER FX TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE NTE COVIDIEN B656007 00821684068342

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention