BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXCATH SELECT STEERABLE SHEATH

    MDR report key: 15226536 · Received August 15, 2022

    Report

    Report Number
    3002648230-2022-00319
    Event Type
    Malfunction
    Date Received
    August 15, 2022
    Date of Event
    May 2, 2022
    Report Date
    August 15, 2022
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    DYB
    UDI-DI
    00763000279905
    PMA / PMN Number
    K142684
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVENT SUMMARY: THE 990065 SHEATH WITH LOT NUMBER 0010878298 WAS RETURNED AND ANALYZED. VISUAL INSPECTION PRIOR TO DISASSEMBLY AND FUNCTIONAL TESTING WAS PERFORMED ON THE SHAFT, HANDLE, AND DILATOR. VISUAL INSPECTION OF THE SHAFT AREA IDENTIFIED A SHAFT KINK/TWIST AT APPROXIMATELY 2.5 INCHES FROM THE TIP. FUNCTIONAL TESTING WAS PERFORMED. INSERTION WAS DIFFICULT DUE TO THE SHAFT KINK. IN CONCLUSION, THE SHEATH FAILED THE RETURNED PRODUCT INSPECTION DUE TO A KINK/TWIST ON THE SHAFT. 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.

    Description of Event or Problem · 0

    AFTER A COMPLETED CASE, THE SHEATH SUBSEQUENTLY TESTED OUT OF SPECIFICATION PER THE MANUFACTURER'S INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1940884 FLEXCATH SELECT STEERABLE SHEATH INTRODUCER, CATHETER DYB MEDTRONIC CRYOCATH LP 990065 0010878298 00763000279905

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown