BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM

    MDR report key: 18952323 · Received March 21, 2024

    Report

    Report Number
    2024168-2024-03586
    Event Type
    Injury
    Date Received
    March 21, 2024
    Date of Event
    March 6, 2024
    Report Date
    June 19, 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
    NL
    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 ANTERIOR CUFF WAS FOUND TO BE NOT RETURNED DURING EVALUATION OF THE RETURNED DEVICE. THE LOCATION OF THE DETACHED CUFF IS UNKNOWN. ADDITIONAL FOLLOW UP INDICATED THE SITE WAS UNAWARE OF THE SEPARATION. IT IS MOST LIKELY THAT THE OBSERVED LINK SEPARATION IS DUE TO POST PROCEDURE HANDLING DURING PACKING FOR RETURNED TO ABBOTT. 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 THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. CORRECTION: D4 - LOT # UPDATED FROM 3102441 TO 3100441.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.

    Description of Event or Problem · 0

    THE ANTERIOR CUFF WAS FOUND TO BE NOT RETURNED DURING EVALUATION OF THE RETURNED DEVICE. THE LOCATION OF THE DETACHED CUFF IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS A VENOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL VEIN WITH A PROSTYLE DEVICE USING THE PRE-CLOSE TECHNIQUE VIA A 7F SHEATH HOLE PRIOR TO AN INTERVENTIONAL PULMONARY VEIN ISOLATION (PVI) PROCEDURE. REPORTEDLY, NO SUTURE WAS FOUND UPON PLUNGER REMOVAL [CUFF MISS]. THE SUTURE OF A NEW PROSTYLE DEVICE WAS SUCCESSFULLY PRE-PLACED. THE SHEATH WAS UPSIZED TO A 16F, AND THE PVI PROCEDURE WAS COMPLETED. HEMOSTASIS WAS ACHIEVED WITH THE PRE-PLACED PROSTYLE SUTURE. THERE WAS NO REPORTED 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
    532076 PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR 3100441 08717648344039

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention