BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® DRYSEAL FLEX INTRODUCER SHEATH

    MDR report key: 15482762 · Received September 26, 2022

    Report

    Report Number
    3007284313-2022-02128
    Event Type
    Malfunction
    Date Received
    September 26, 2022
    Date of Event
    August 26, 2022
    Report Date
    October 20, 2022
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    DYB
    UDI-DI
    00733132628346
    PMA / PMN Number
    K160254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    W. L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE A LEGAL ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY DEFECTS OR HAS MALFUNCTIONED, AS DEFINED FROM A LEGAL STANDPOINT. THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Additional Manufacturer Narrative · 0

    ENGINEERING EVALUATION COMPLETED (SEE ATTACHMENT). C AND D CODES UPDATED.

    Description of Event or Problem · 0

    ON (B)(6) 2022, THIS PATIENT UNDERWENT A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVI) FOR A VALVULAR HEART DISEASE USING A GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF). BEFORE INSERTING THE DELIVERY CATHETER, A BALLOON CATHETER (Z-MEDII, PDZ652) WAS ADVANCED THROUGH THE DSF AND BALLOON EXPANSION OF THE AORTIC VALVE WAS PERFORMED. THE BALLOON WAS GETTING IN AND OUT OF THE DSF FOR 3 TIMES DURING THIS STEP. THEREAFTER THE PHYSICIAN NOTICED THAT THE MARKER ON THE LEADING TIP WAS SEPARATED FROM THE DSF WHEN HE WAS WITHDRAWING IT. THE DSF WAS WITHDRAWN AND ANOTHER DSF (DSF1833) WAS USED FOR THE REST OF THE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE. NO INJURY TO THE PATIENT WAS REPORTED. THE DEVICE WAS RETURNED TO GORE FOR FURTHER INVESTIGATION. ADDITIONAL INFORMATION WAS RECEIVED VIA THE FSA ON AUGUST 30, 2022, AS FOLLOWS. TAVI WAS PERFORMED VIA THE RIGHT FEMORAL APPROACH (CUT-DOWN). THE DSF WAS INSERTED OVER A STIFF-TYPE GUIDEWIRE (SAFARI). THE DSF WAS ADVANCED TO THE LEVEL WHERE THE DSF TIP WAS JUST PROXIMAL TO THE ARCH, AND THE SAFARI WAS INSERTED IN THE LEFT VENTRICLE. WHEN ADVANCING THE WIRE, THE DSF WAS MOVED A LITTLE DISTALLY. THEREFORE, THE PHYSICIAN INSERTED THE DILATOR AND ADVANCED THE DSF TO THE LEVEL JUST BEYOND THE ARCH AGAIN. THE MARKER ON THE LEADING TIP MAY HAVE BEEN SEPARATED WHEN THE DILATOR WAS REMOVED. THE PHYSICIAN FELT STRANGE SENSATION REGARDING THE BEHAVIOR OF THE MARKER PORTION, BUT HE DID NOT NOTICE THE SEPARATION AND INSERTED A BALLOON CATHETER TO DILATE THE AORTIC VALVE. THEN THE PHYSICIAN ATTEMPTED TO INSERT THE TAVI DEVICE, HOWEVER, IT WAS CAUGHT IN THE DSF TIP MARKER AND HE COULD NOT ADVANCE IT. A BALLOON CATHETER WAS INSERTED TO DILATE THE DSF RADIOPAQUE MARKER AND HE REMOVED THE MARKER TOGETHER WITH THE SHEATH. THE PHYSICIAN WAS ABLE TO RETRIEVE THE MARKER, BUT THERE WAS A POSSIBILITY THAT A PART OF OUTER SHEATH LAYER REMAINED IN THE PATIENT¿S BODY. THE REPORTING PHYSICIAN THOUGHT THAT THIS EVENT WAS A DEVICE MALFUNCTION AS HE DID NOT USE THE DSF ROUGHLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2077906 GORE® DRYSEAL FLEX INTRODUCER SHEATH INTRODUCER, CATHETER DYB W. L. GORE & ASSOCIATES, INC. DSF1865 00733132628346

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention