BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE¿ PROSTYLE¿

    MDR report key: 20158665 · Received September 6, 2024

    Report

    Report Number
    2024168-2024-10524
    Event Type
    Injury
    Date Received
    September 6, 2024
    Date of Event
    August 6, 2024
    Report Date
    November 12, 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
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTIONS WERE PERFORMED ON THE RETURNED DEVICE. THE UNSPECIFIED FAILURE WAS OBSERVED AS A NEEDLE TO LINK DETACHMENT. LOT HISTORY RECORD (LHR) AND CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. THE LINK BREAK AND SUBSEQUENT TREATMENT APPEAR TO BE RELATED TO AN INTERACTION OF THE DEVICE WITH PATIENT ANATOMY, LINK 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. B3 CORRECTION: DATE OF EVENT UPDATED FROM 8/14/2024 TO 8/6/2024. D4 CORRECTION: CATALOG # AND MODEL # UPDATED FROM UNK PROSTYLE TO # 12773-02. D4 CORRECTION: LOT # UPDATED FROM UNKNOWN TO 3040341. D4 CORRECTION: PRIMARY UDI NUMBER UPDATED FROM UNKNOWN TO (B)(4). D9 CORRECTION: DEVICE AVAILABLE FOR EVALUATION UPDATED FROM NO TO YES E1 CORRECTION: INITIAL REPORTER UPDATED TO (B)(6).

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. B3: ESTIMATED DATE D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS A CLOSURE USING A PROSTYLE DEVICE RELATIVE TO AN UNSPECIFIED PROCEDURE. REPORTEDLY, AN UNSPECIFIED PRODUCT EXPERIENCE OCCURRED. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2074294 PERCLOSE¿ PROSTYLE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12773-02 3040341 08717648344039

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention