BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE¿ PROSTYLE¿

    MDR report key: 21208435 · Received January 22, 2025

    Report

    Report Number
    2024168-2025-00753
    Event Type
    Injury
    Date Received
    January 22, 2025
    Date of Event
    December 24, 2024
    Report Date
    February 18, 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
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED DIFFICULT TO CLOSE WAS NOT CONFIRMED DUE TO DEVICE CONDITION. THE REPORTED ENTRAPMENT COULD NOT BE CONFIRMED AS THE EXACT CONDITIONS ENCOUNTERED BY THE DEVICE DURING THE PROCEDURE COULD NOT BE REPLICATED IN THE TEST ENVIRONMENT. 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 OF SPECIFIC ISSUE. BASED ON THE INFORMATION PROVIDED, A DEFINITIVE CAUSE FOR THE REPORTED ISSUES COULD NOT BE DETERMINED. FACTORS THAT CONTRIBUTE TO THE INABILITY TO RETRACT THE FOOT, INCLUDE, BUT NOT LIMITED TO TISSUE OR SUTURE CAUGHT IN FOOT. THE INABILITY TO CLOSE THE FOOT LIKELY CONTRIBUTED TO THE DEVICE ENTRAPMENT. THE TREATMENT APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. ADDITIONALLY, EIGHT STERILE/UNUSED DEVICES WITH LOT # 4101741 WERE SUCCESSFULLY TESTED WITH NO ANOMALIES NOTED. AS SUCH, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE. B5 - DESCRIBE EVENT OR PROBLEM: UPDATED H6 - HEALTH EFFECT - IMPACT CODES 4607 AND 4604 ADDED. H6 - MEDICAL DEVICE PROBLEM CODE 1212 ADDED.

    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

    SUBSEQUENT TO PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED: IT WAS REPORTED THAT THIS WAS AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY USING A PROSTYLE AFTER A PERIPHERAL INTERVENTION WITH A 6F SHEATH. REPORTEDLY, THE SUTURE DEPLOYED PROPERLY. WHEN THE LEVER WAS RETRACTED, THE FOOTPLATE DID NOT CLOSE. THE DEVICE WAS MANUALLY BROKEN OPEN TO CLOSE THE FEET; HOWEVER, THE DEVICE COULD NOT BE RELEASED. THE PATIENT WAS SENT TO SURGERY FOR A CUT DOWN TO REMOVE THE DEVICE. SURGICAL SUTURING WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS A REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. HOSPITALIZATION WAS PROLONGED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS A VESSEL CLOSURE OF AN UNKNOWN VESSEL USING A PROSTYLE RELATIVE TO AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE PROSTYLE FOOT WOULD NOT CLOSE. THE DEVICE WAS MANIPULATED WITH ATTEMPTING TO PUSH DOWN THE ACTUATOR WIRE AND CLOSE THE FOOT WITHOUT SUCCESS. THE BODY OF THE PROSTYLE WAS BROKEN APART. THE PATIENT WAS SENT TO SURGERY WHERE THE PROSTYLE WAS COMPLETELY SEPARATED, REMOVED, AND THE ACCESS SITE WAS CLOSED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621900 PERCLOSE¿ PROSTYLE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12773-03 4101741 08717648235184

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention