BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE¿ PROSTYLE¿

    MDR report key: 20359826 · Received October 3, 2024

    Report

    Report Number
    2024168-2024-11634
    Event Type
    Injury
    Date Received
    October 3, 2024
    Date of Event
    August 6, 2024
    Report Date
    December 5, 2024
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    UDI-DI
    08717648344039
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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.

    Additional Manufacturer Narrative · 0

    VISUAL AND FUNCTIONAL ANALYSIS WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED FAILURE TO FIRE WAS OBSERVED AS A NEEDLE TO CUFF MIS. PRODUCTION RECORD AND CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. THE INVESTIGATION DETERMINED THAT 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. BASED ON THE REPORTED INFORMATION AND RESULTS OF THE COMPLAINT INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. THE ADDITIONAL DEVICE REFERENCED IN B5 IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER. B5: DESCRIBE EVENT OR PROBLEM: UPDATED. D4: LOT # UPDATED FROM 4071541 TO 4062541. D4: EXPIRATION DATE CORRECTED FROM 6/30/2026 TO 5/31/2026. D4: PRIMARY UDI NUMBER CORRECTED FROM (B)(4). H4: DEVICE MFG DATE CORRECTED FROM 7/15/2024 TO 6/25/2024.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF AN UNSPECIFIED ACCESS SITE WAS ATTEMPTED USING A PROSTYLE DEVICE RELATIVE TO AN UNSPECIFIED PROCEDURE. REPORTEDLY, LOCKING SYSTEM COULD NOT BE TRIGGERED [FAILURE TO FIRE]. THE METHOD USED TO ACHIEVE HEMOSTASIS WAS NOT PROVIDED. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF AN UNSPECIFIED ACCESS SITE WAS ATTEMPTED USING A PROSTYLE DEVICE RELATIVE TO AN UNSPECIFIED PROCEDURE. REPORTEDLY, LOCKING SYSTEM COULD NOT BE TRIGGERED [FAILURE TO FIRE]. THE METHOD USED TO ACHIEVE HEMOSTASIS WAS NOT PROVIDED. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. DURING RETURNED DEVICE ANALYSIS, AN ADDITIONAL DEVICE WAS RETURNED. THE SUTURE WAS RETURNED PARTIALLY REMOVED FROM THE GUIDE TUBE WITH DRY BLOOD WAS NOTED. THE KNOT AND LOOP OF THE RETURNED SUTURE WERE NOT FORMED. THE POSTERIOR NEEDLE TIP WAS EJECTED FROM THE POSTERIOR NEEDLE SHANK, REMAINED CONNECTED TO THE SUTURE, AND RETURNED WITH NO VISIBLE DAMAGE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2015622 PERCLOSE¿ PROSTYLE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12773-02 4062541 08717648344039

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention