BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE¿ PROSTYLE¿

    MDR report key: 19176050 · Received April 24, 2024

    Report

    Report Number
    2024168-2024-05062
    Event Type
    Injury
    Date Received
    April 24, 2024
    Date of Event
    April 3, 2024
    Report Date
    July 11, 2024
    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
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED ¿NO BLOOD FLOW WAS OBSERVED AT THE MARKER LUMEN¿ WAS CONFIRMED. PRODUCTION RECORD AND CORRECTIVE AND PREVENTIVE ACTION (CAPA) REVIEWS WERE PERFORMED AND REVEALED THAT THIS EVENT HAS BEEN DEEMED TO BE RELATED TO A POTENTIAL PRODUCT QUALITY ISSUE. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A LOT SPECIFIC QUALITY ISSUE. THE REPORTED OBSTRUCTION OF FLOW WAS CONCLUDED TO BE RELATED TO POTENTIAL PRODUCT QUALITY ISSUE DUE TO ADHESIVE OBSTRUCTING THE MARKER PORT. THE ISSUE IS BEING ADDRESSED PER INTERNAL OPERATING PROCEDURES. ABBOTT VASCULAR WILL CONTINUE TO TREND THE PERFORMANCE OF THESE DEVICES. CORRECTIONS: D1 ¿ BRAND NAME: UPDATED. D2A ¿ COMMON DEVICE NAME: UPDATED. D3 ¿ NAME, ADDRESS 1, CITY, POSTAL CODE: UPDATED. D4 - LOT #: UPDATED FROM 3092941 TO 3101641. D4 - EXPIRATION DATE: UPDATED. D4 - PRIMARY UDI NUMBER: UPDATED. H4 - DEVICE MFG DATE: UPDATED.

    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 DEVICES REFERENCED IN B5 ARE FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS A VENOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL VEIN USING A PROSTYLE DEVICE AFTER A CARDIAC ABLATION INTERVENTIONAL PROCEDURE USING AN 8F SHEATH. REPORTEDLY, THERE WAS NO BLOOD FLOW OBSERVED FROM THE MARKER LUMEN WHEN THE PROSTYLE DEVICE WAS ADVANCED AND POSITIONED IN THE VEIN. AN ATTEMPT WAS MADE WITH TWO ADDITIONAL PROSTYLE DEVICES; HOWEVER, A CUFF MISS [SUTURE RETRIEVAL ISSUE] WAS NOTICED WITH BOTH DEVICES. MANUAL COMPRESSION WAS APPLIED 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
    583522 PERCLOSE¿ PROSTYLE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12773-03 3101641 08717648235184

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention