BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE¿ PROSTYLE¿

    MDR report key: 17959388 · Received October 18, 2023

    Report

    Report Number
    2024168-2023-11518
    Event Type
    Injury
    Date Received
    October 18, 2023
    Date of Event
    August 24, 2023
    Report Date
    July 22, 2024
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    UDI-DI
    08717648235184
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    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. THE ADDITIONAL PERCLOSE PROSTYLE DEVICES REFERENCED IN B5 ARE FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS.

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTIONS WERE PERFORMED ON THE RETURNED DEVICE. THE REPORTED A 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. 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 - LOT NUMBER UPDATED FROM UNKNOWN TO 3060141. H6: DEVICE CODE 1562 REMOVED AND 1142 ADDED.

    Additional Manufacturer Narrative · 0

    E4: INITIAL REPORT SENT TO FDA UPDATED FROM NO TO YES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS A CLOSURE USING THREE PROSTYLE DEVICES RELATIVE TO AN UNSPECIFIED PROCEDURE. REPORTEDLY, A SUTURE BREAK OCCURRED WITH THE THREE PROSTYLE DEVICES. 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

    SUBSEQUENT TO THE INITIALLY FILED REPORT, THE FOLLOWING INFORMATION WAS RECEIVED: THIS WAS A CARDIAC ABLATION INTERVENTIONAL PROCEDURE. ANOTHER PROSTYLE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    USER FACILITY MEDWATCH REPORT RECEIVED THAT STATES, ¿DESCRIBE THE EVENT OR PROBLEM: SUTURE BROKE ON 3 DEVICES. THIS HAS BEEN REPORTED TO ABBOTT VASCULAR. WHAT WAS THE ORIGINAL INTENDED PROCEDURE?: CRYO AF. WHAT PROBLEM DID THE USER HAVE (CHECK ALL THAT APPLY): DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING). THE REPORTED "SUTURE BROKE ON 3 DEVICES." WAS PREVIOUSLY CONFIRMED TO BE REFERRING TO "A CUFF MISS OCCURRED WITH THE THREE PROSTYLE DEVICES". NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617874 PERCLOSE¿ PROSTYLE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12773-03 3060141 08717648235184

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Required Intervention