BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE¿ PROSTYLE¿

    MDR report key: 19669954 · Received July 3, 2024

    Report

    Report Number
    2024168-2024-07973
    Event Type
    Injury
    Date Received
    July 3, 2024
    Date of Event
    June 5, 2024
    Report Date
    August 16, 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
    FI
    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 PROSTYLE DEVICE REFERENCED IN B5 IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR ANALYSIS. THERE IS NO APPARENT DEVICE MALFUNCTION OR DAMAGE. PRODUCTION RECORD AND CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED THERE IS NO INDICATION OF A LOT SPECIFIC ISSUE. ANALYSIS WILL NOT BE REQUIRED AS THERE WAS NO DEVICE MALFUNCTION OR ADVERSE EVENT ASSOCIATED WITH THIS DEVICE. B5: DESCRIBE EVENT OR PROBLEM: UPDATED. D4: LOT NUMBER UPDATED FROM 3110143 TO 4011042. H6: HEALTH EFFECT - IMPACT CODE UPDATED FROM 4641 TO 2199. H6: MEDICAL DEVICE PROBLEM CODE UPDATED FROM 3190 TO 3189.

    Description of Event or Problem · 0

    THIS WAS REPORTED AS AN ARTERIOTOMY CLOSURE OF THE MILDLY CALCIFIED COMMON FEMORAL ARTERY USING THE PRE-CLOSE TECHNIQUE. REPORTEDLY, THE DEVICE WAS DEPLOYED AND LEVER WAS CLOSED; HOWEVER, UPON REMOVAL OF THE PROSTYLE DEVICE, IT WAS NOTED THAT THE FOOT DID NOT FULLY CLOSE. THE LEVER WAS SWUNG BACK AND FORTH A COUPLE OF TIMES UNTIL THE FOOT OPENED COMPLETELY. IT IS UNKNOWN IF HEMOSTASIS WAS ACHIEVED WITH THE COMPLAINT DEVICE OR AN ALTERNATE CLOSURE METHOD. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. FURTHER FOLLOW UP WITH THE ACCOUNT WAS CONDUCTED AND IT WAS INDICATED THAT THERE WAS ONE OR TWO DEVICES USED DURING THE PROCEDURE SO (B)(6) WAS ADDED TO CAPTURE AN ADDITIONAL DEVICE. HOWEVER, IT IS UNCLEAR WHETHER THERE WAS AN ISSUE WITH THE DEVICE AS THE SITE STATED ALL DEVICES BEING RETURNED HAD BEEN USED; HOWEVER, SOME MAY HAVE BEEN SUCCESSFULLY USED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    SUBSEQUENT TO FILING THE INITIAL REPORT, THE FOLLOWING INFORMATION WAS RECEIVED: REPORTEDLY, A NEW PROSTYLE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. ANALYSIS OF THE DEVICE RETURNED FOR THIS COMPLAINT WAS CONSISTENT WITH A SUCCESSFULLY USED DEVICE, WHICH ALIGNS WITH THE REPORTED USE OF A SECOND DEVICE FOR CLOSURE. ANALYSIS OF THE DEVICE RETURNED FOR CN-238924 (PREVIOUSLY FILED UNDER REPORT REF # 2024168-2024-07574-02) WAS CONSISTENT WITH A SUTURE MALPOSITION. ADDITIONAL FOLLOW UP WITH THE SITE WAS PERFORMED; HOWEVER, THE ACCOUNT CONTACT WAS NO LONGER AVAILABLE TO PROVIDE CLARIFICATION ON THE DEVICE ISSUE. 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
    473775 PERCLOSE¿ PROSTYLE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12773-02 4011042 08717648344039

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention