BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE¿ PROSTYLE¿

    MDR report key: 21286739 · Received January 31, 2025

    Report

    Report Number
    2024168-2025-01173
    Event Type
    Injury
    Date Received
    January 31, 2025
    Date of Event
    January 17, 2025
    Report Date
    October 17, 2025
    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
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED NEEDLE TO CUFF MISS WAS CONFIRMED. PRODUCTION RECORD AND CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. THE REPORTED DIFFICULTY AND SUBSEQUENT TREATMENT APPEAR TO BE RELATED TO OPERATIONAL CONTEXT. IT IS LIKELY THAT 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 INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. CORRECTION: D4 - LOT #: UPDATED FROM 4103041 TO 4083042. D4 - EXPIRATION DATE: UPDATED FROM 9/30/2026 TO 7/31/2026. D4 - PRIMARY UDI NUMBER: UPDATED FROM (B)(4) TO (B)(4). D9 - DEVICE AVAILABLE FOR EVALUATION: UPDATED FROM NO TO YES. H4 - DEVICE MFG DATE: UPDATED FROM 10/30/2024 TO 8/30/2024.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. PRODUCTION RECORD AND CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. THE REPORTED DIFFICULTY 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 INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. CORRECTIONS: D4 LOT #: UPDATED FROM 4083042 TO 4103041. D4 EXPIRATION DATE: UPDATED FROM 7/31/2026 TO 9/30/2026. D4 PRIMARY UDI NUMBER: UPDATED FROM (B)(4) TO (B)(4). D9 DEVICE AVAILABLE FOR EVALUATION: UPDATED FROM YES TO NO. D9 DATE RETURNED TO MFG: UPDATED - DATE OF 2/7/2025 WAS REMOVED, AS THE DEVICE WAS NOT RETURNED. H4 DEVICE MFG DATE: UPDATED FROM 8/30/2024 TO 10/30/2024. H6 COMPONENT CODE: CODES 3088, 1028 AND 562 WERE REMOVED AND CODE 4755 WAS ADDED. H6 TYPE OF INVESTIGATION: CODE 10 WAS REMOVED AND CODES 1411, 3331 AND 4115 WERE ADDED. H11 ADDITIONAL MFG NARRATIVE: UPDATED, AS THE DEVICE WAS NOT RETURNED.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. PRODUCTION RECORD AND CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. THE REPORTED DIFFICULTY 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 INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS A VENOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL VEIN USING A PROSTYLE DEVICE AFTER AN UNSPECIFIED INTERVENTIONAL PROCEDURE USING A SMALL BORE SHEATH (</=8F). REPORTEDLY, A CUFF MISS [SUTURE RETRIEVAL ISSUE] WAS NOTICED. ANOTHER PROSTYLE DEVICE 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494525 PERCLOSE¿ PROSTYLE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12773-03 4103041 08717648235184

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention