BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE

    MDR report key: 20248272 · Received September 18, 2024

    Report

    Report Number
    2024168-2024-11030
    Event Type
    Injury
    Date Received
    September 18, 2024
    Date of Event
    August 30, 2024
    Report Date
    December 4, 2024
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    UDI-DI
    08717648079474
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN ANALYSIS WAS PERFORMED ON THE RETURNED DEVICE. THE MECHANICAL JAM WAS CONFIRMED. THE REPORTED LEAK ¿BLOOD WAS BLEEDING OUT OF THE VALVE OF THE SHEATH¿ COULD NOT BE CONFIRMED AS THE EXACT CONDITIONS ENCOUNTERED BY THE DEVICE DURING THE PROCEDURE COULD NOT BE REPLICATED IN THE TEST ENVIRONMENT. PRODUCTION RECORD AND CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED THERE IS NO INDICATION OF A LOT SPECIFIC ISSUE. IT WAS REPORTED THE DEVICE WAS USED AFTER DAMAGE TO THE SHEATH. IT SHOULD BE NOTED THE STARCLOSE INSTRUCTIONS FOR USE, IFU, SECTION WARNINGS, STATES ¿DO NOT USE THE STARCLOSE SE VASCULAR CLOSURE SYSTEM IF THE PACKAGING OR STERILE BARRIER HAS BEEN PREVIOUSLY OPENED OR DAMAGED OR IF THE COMPONENTS APPEAR TO BE DAMAGED OR DEFECTIVE. IT IS UNKNOWN IF THE IFU VIOLATION CONTRIBUTED TO THE REPORTED ISSUES. BASED ON THE REPORTED INFORMATION AND THE OBSERVATIONS FROM THE RETURNED DEVICE ANALYSIS, THE INVESTIGATION DETERMINED THAT THE REPORTED ISSUE APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. IN THIS CASE, THE SEAL VALVE IN THE HUB OF THE SHEATH WAS DISTORTED LIKELY THROUGH INTERACTION WITH THE GUIDE WIRE OR INTRODUCER. THE DISTORTION WOULD PREVENT THE SEAL FROM CLOSING PROPERLY ALLOWING BLOOD TO FLOW AND WOULD LIKELY ALSO BE THE CAUSE OF THE DIFFICULTY WITH DEPRESSING THE PLUNGER. WHEN THE CLOSURE DEVICE IS INSERTED INTO THE HUB, THE CUTTER IS INSERTED AT THE VERY END AND ENDS UP JUST INSIDE THE HUB AND SEAL. WITH THE SEAL DISTORTED, IT LIKELY CAUGHT THE CUTTER BLADE WHICH LED TO THE BREAK OBSERVED IN THE RETURNED DEVICE ANALYSIS. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. B5 - DESCRIBE EVENT OR PROBLEM: UPDATED. D4 - LOT # UPDATED FROM 4042941 TO 4042341. H6 - MEDICAL DEVICE PROBLEM CODE 1371 WAS REMOVED; 1354 AND 2017 ADDED.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS AN ARTERIOTOMY CLOSURE OF THE LEFT COMMON FEMORAL ARTERY USING A STARCLOSE AFTER A POPLITEAL ANGIOPLASTY/STENT INTERVENTIONAL PROCEDURE USING A SMALL-BORE ARTERY (= 8F) SHEATH. REPORTEDLY, IT WAS NOTED THAT WHEN PUSHING THE PLUNGER INTO PLACE (NUMBER 2), IT WAS VERY DIFFICULT, HOWEVER, STEP 2 WAS ABLE TO BE COMPLETED. THE ADDITIONAL STEPS 3 AND 4 WERE ALSO COMPLETED WITHOUT ISSUE. THE DEVICE WAS DEPLOYED AS PER NORMAL STEPS, BUT WHEN THE WIRE AND DILATOR WERE REMOVED FROM THE STARCLOSE SHEATH, IT WAS NOTED THAT BLOOD WAS BLEEDING OUT OF THE VALVE OF THE SHEATH AND THEREFORE HEMOSTASIS WAS NOT ACHIEVED. MANUAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. SUBSEQUENT TO THE INITIALLY FILED MDR, CASE INFORMATION WAS RE-ASSESSED: REPORTEDLY, WHEN THE WIRE AND DILATOR WERE REMOVED FROM THE STARCLOSE SHEATH, IT WAS NOTED THAT BLOOD WAS BLEEDING OUT OF THE VALVE OF THE SHEATH. THE DEVICE WAS INSERTED AND IT WAS NOTED THAT WHEN PUSHING THE PLUNGER INTO PLACE (NUMBER 2), IT WAS VERY DIFFICULT, HOWEVER, STEP 2 WAS ABLE TO BE COMPLETED. THE ADDITIONAL STEPS 3 AND 4 WERE ALSO COMPLETED WITHOUT ISSUE. THE DEVICE WAS DEPLOYED AS PER NORMAL STEPS, BUT HEMOSTASIS WAS NOT ACHIEVED. MANUAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS AN ARTERIOTOMY CLOSURE OF THE LEFT COMMON FEMORAL ARTERY USING A STARCLOSE AFTER A POPLITEAL ANGIOPLASTY/STENT INTERVENTIONAL PROCEDURE USING A SMALL-BORE ARTERY (= 8F) SHEATH. REPORTEDLY, IT WAS NOTED THAT WHEN PUSHING THE PLUNGER INTO PLACE (NUMBER 2), IT WAS VERY DIFFICULT, HOWEVER, STEP 2 WAS ABLE TO BE COMPLETED. THE ADDITIONAL STEPS 3 AND 4 WERE ALSO COMPLETED WITHOUT ISSUE. THE DEVICE WAS DEPLOYED AS PER NORMAL STEPS, BUT WHEN THE WIRE AND DILATOR WERE REMOVED FROM THE STARCLOSE SHEATH, IT WAS NOTED THAT BLOOD WAS BLEEDING OUT OF THE VALVE OF THE SHEATH AND THEREFORE HEMOSTASIS WAS NOT ACHIEVED. MANUAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1302302 STARCLOSE SE DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 14679-02 4042341 08717648079474

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention