BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE¿ PROSTYLE¿

    MDR report key: 19361281 · Received May 21, 2024

    Report

    Report Number
    2024168-2024-06168
    Event Type
    Injury
    Date Received
    May 21, 2024
    Date of Event
    May 2, 2024
    Report Date
    September 19, 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
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. PRODUCTION RECORD AND CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. THE REPORTED DIFFICULTIES AND SUBSEQUENT TREATMENT APPEAR TO BE RELATED TO AN INTERACTION OF THE DEVICE WITH PATIENT ANATOMY, SUTURE PULLED UNTIL IT BREAKS 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. ADDITIONAL INFORMATION: D4 - MODEL # ADDED. CORRECTIONS: D1 - BRAND NAME UPDATED. D2A - COMMON DEVICE NAME UPDATED. D3 - NAME UPDATED. D3 - ADDRESS, CITY, POSTAL CODE UPDATED. D4: LOT NUMBER UPDATED FROM 4032541 TO 4021741. H6: HEALTH EFFECT - CLINICAL AND IMPACT CODE 1888 REMOVED; 4582 ADDED. H6: MEDICAL DEVICE PROBLEM CODE 4001 REMOVED; 1562 ADDED.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. B3: DATE OF EVENT IS ESTIMATED THE ADDITIONAL DEVICES REFERENCED IN B5 ARE FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS A VESSEL PUNCTURE CLOSURE OF AN UNKNOWN VESSEL USING A PROSTYLE DEVICE. REPORTEDLY, THE DEVICE FAILED TO ACHIEVE HEMOSTASIS AND CAUSED ISSUES WITH BLEEDING. ANOTHER 7 PROSTYLES WERE USED BUT THE SAME ISSUE OCCURRED. THE METHOD TO ACHIEVE HEMOSTASIS WAS NOT SPECIFIED. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. SUBSEQUENT TO THE INITIALLY FILED MDR REPORT, ADDITIONAL INFORMATION WAS OBTAINED: IT WAS REPORTED THAT THIS WAS A VENOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL VEIN USING A PROSTYLE DEVICE AFTER AN INTERVENTIONAL CRYO ABLATION PROCEDURE. REPORTEDLY, ALL 8 PROSTYLE SUTURES BROKE WHICH IS THE REASON THE DEVICES FAILED TO ACHIEVE HEMOSTASIS. ANOTHER PROSTYLE 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS A VESSEL PUNCTURE CLOSURE OF AN UNKNOWN VESSEL USING A PROSTYLE DEVICE. REPORTEDLY, THE DEVICE FAILED TO ACHIEVE HEMOSTASIS AND CAUSED ISSUES WITH BLEEDING. ANOTHER 7 PROSTYLES WERE USED BUT THE SAME ISSUE OCCURRED. THE METHOD TO ACHIEVE HEMOSTASIS WAS NOT SPECIFIED. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1155418 PERCLOSE¿ PROSTYLE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12773-02 4021741 08717648344039

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention