BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM

    MDR report key: 18039826 · Received October 31, 2023

    Report

    Report Number
    2024168-2023-12018
    Event Type
    Injury
    Date Received
    October 31, 2023
    Date of Event
    October 12, 2023
    Report Date
    January 5, 2024
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. H6: MEDICAL DEVICE PROBLEM CODE 2017- IMPROPER OR INCORRECT PROCEDURE OR METHOD CLARIFIER FAILURE TO FOLLOW STEPS / INSTRUCTIONS WAS ADDED TO CAPTURE NO FEMORAL IMAGING WAS PERFORMED.

    Additional Manufacturer Narrative · 0

    ANALYSIS WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED NEEDLE TO CUFF MISS WAS CONFIRMED. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. REPORTEDLY, FEMORAL IMAGING WAS NOT PERFORMED. IT SHOULD BE NOTED THAT THE ELECTRONIC PERCLOSE PROSTYLE INSTRUCTIONS FOR USE (EIFU), STATES: PERFORM A FEMORAL ANGIOGRAM TO VERIFY THE LOCATION OF THE PUNCTURE SITE. THE REPORTED DIFFICULTIES AND SUBSEQUENT TREATMENT APPEAR TO BE RELATED TO AN INTERACTION OF THE DEVICE WITH PATIENT ANATOMY OR INABILITY TO MAINTAIN POSITION/STABILITY OF THE DEVICE DURING DEPLOYMENT DUE TO CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.D4 - CATALOG # UPDATED FROM "UNK PROSTYLE" TO 12773-02 D4 - LOT # UPDATED FROM "UNKNOWN" TO 3061342. H6 - MEDICAL DEVICE PROBLEM CODE 1562 REMOVED, 1142 ADDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THIS WAS AN ARTERIOTOMY CLOSURE OF A COMMON FEMORAL ARTERY USING ONLY ONE PROSTYLE DEVICE USING THE PRE-CLOSE TECHNIQUE PRIOR TO AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE. FEMORAL IMAGING WAS NOT PERFORMED. REPORTEDLY, AFTER CLOSING THE FOOT, THE PISTON SEPARATED ON THE PROSTYLE DEVICE. THE SHEATH WAS UPSIZED TO A 9F SHEATH AND THE EVAR PROCEDURE WAS COMPLETED. HEMOSTASIS WAS ACHIEVED VIA SURGERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE INITIALLY FILED REPORT, THE FOLLOWING INFORMATION WAS RECEIVED: REPORTEDLY, AFTER CLOSING THE FOOT, THE PISTON SEPARATED [PLUNGER WAS REMOVED WITH NO SUTURE CONNECTED] ON THE PROSTYLE DEVICE. A FOOT SEPARATION DID NOT OCCUR. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2226273 PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR 3061342

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention