BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM

    MDR report key: 17347147 · Received July 18, 2023

    Report

    Report Number
    2024168-2023-07681
    Event Type
    Injury
    Date Received
    July 18, 2023
    Date of Event
    June 26, 2023
    Report Date
    August 31, 2023
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    UDI-DI
    08717648235184
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED DEVICE ENTRAPMENT COULD NOT BE CONFIRMED AS THE EXACT CONDITIONS ENCOUNTERED BY THE DEVICE DURING THE PROCEDURE COULD NOT BE REPLICATED IN THE TEST ENVIRONMENT. THE LEVER WAS IN A CLOSED POSITION AND THE FOOT WAS PARTIALLY RETRACTED. STERILE DEVICES WERE SUCCESSFULLY TESTED WITH NO ANOMALIES NOTED. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY DID NOT INDICATE A LOT SPECIFIC QUALITY ISSUE. THE PATIENT EFFECTS OF HEMORRHAGE AND TISSUE INJURY ARE LISTED IN THE PROSTYLE INSTRUCTIONS FOR USE (IFU) AS POTENTIAL ADVERSE EVENT ASSOCIATED WITH USE OF THE VESSEL CLOSURE DEVICES. BASED ON THE RETURNED DEVICE ANALYSIS AND THE INFORMATION REPORTED, THE REPORTED DEVICE ENTRAPMENT APPEARS TO BE RELATED TO INTERACTION WITH THE PATIENT TISSUE OR VESSEL. IN THIS CASE, IT IS POSSIBLE THE ISSUE WITH THE FOOT PLATE IS DUE TO INTERFERENCE WITH TISSUE OR SUTURE UNDER THE ANTERIOR FOOT CAUSING THE FOOT TO SURF DISTALLY SETTING THE ANTERIOR FOOT OUTSIDE THE POCKET INHIBITING CLOSURE AND LEADING TO DIFFICULTY REMOVING INCLUDING ENTRAPMENT. ENSURING THE DEVICE FOOT IS OFF THE VESSEL WALL AND A MARK IS INDICATED BEFORE THE ATTEMPTING TO CLOSE THE FOOT IS THE RECOMMEND PROCEDURE PER THE IFU. THE SUBSEQUENT TREATMENT APPEARS TO BE RELATED TO PROCEDURE CIRCUMSTANCE. THE REPORTED PATIENT EFFECT OF HEMORRHAGE AND TISSUE INJURY IS KNOWN INHERENT RISK 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.D4; LOT NUMBER CHANGED FROM 3010741 TO 3031641. D4: EXPIRATION DATE. H4: MANUFACTURING DATE.

    Additional Manufacturer Narrative · 0

    THE ADDITIONAL PROSTYLE DEVICE REFERENCED IN B5 IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER. 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

    IT WAS REPORTED THAT CLOSURE OF AN UNSPECIFIED ACCESS SITE WAS ATTEMPTED USING TWO PROSTYLE DEVICES RELATIVE TO AN INTERVENTIONAL PROCEDURE. REPORTEDLY WITH BOTH DEVICES, IT WAS AN UNEVENTFUL DEPLOYMENT WITH FULL FOOT PLATE RETRACTION, AND UPON RETRACTION IT FELT A LITTLE STUCK. A PIECE OF TISSUE, MAYBE EVEN ARTERY, WAS NOTED ON THE DEVICE. THIS RESULTED IN A SURGICAL CUT DOWN AND REPAIR. 500 CC OF BLOOD LOSS WAS REPORTED. THERE WAS 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
    862476 PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR 12773-03 3031641 08717648235184

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention