BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM

    MDR report key: 19016319 · Received April 1, 2024

    Report

    Report Number
    2024168-2024-04035
    Event Type
    Injury
    Date Received
    April 1, 2024
    Date of Event
    March 8, 2024
    Report Date
    May 20, 2024
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    UDI-DI
    08717648344039
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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 DEVICE REFERENCED IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED SUTURE RETRIEVAL ISSUE WAS CONFIRMED AS A LINK SEPARATION LOT HISTORY RECORD (LHR) AND CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. THE INVESTIGATION DETERMINED THAT THE OBSERVED LINK SEPARATION AND UNEXPECTED MEDICAL INTERVENTION APPEAR TO BE RELATED TO OPERATIONAL CONTEXT. IT IS LIKELY THAT AN INTERACTION OF THE DEVICE WITH PATIENT ANATOMY OR LINK PULLED UNTIL IT BREAKS 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 3032841 TO 3040442. D4 - EXPIRATION DATE: UPDATED. D4 - PRIMARY UDI NUMBER: UPDATED. H4 - DEVICE MFG DATE: UPDATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS A CLOSURE OF A RIGHT COMMON FEMORAL ARTERY USING TWO PROSTYLE DEVICES AFTER AN INTERVENTIONAL PERCUTANEOUS CORONARY INTERVENTION PROCEDURE WITH A 6FR SHEATH. REPORTEDLY, A CUFF MISS [SUTURE RETRIEVAL ISSUE] OCCURRED WITH BOTH DEVICES. MANUAL COMPRESSION 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
    1767512 PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR 3040442 08717648344039

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention