BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE¿

    MDR report key: 22739603 · Received August 7, 2025

    Report

    Report Number
    2024168-2025-08187
    Event Type
    Injury
    Date Received
    August 7, 2025
    Date of Event
    November 1, 2018
    Report Date
    August 7, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. THE PRODUCTION RECORDS FOR THIS PRODUCT COULD NOT BE REVIEWED AND A SIMILAR COMPLAINT QUERY COULD NOT BE PERFORMED BECAUSE THE PART AND LOT NUMBER WAS NOT REPORTED, AND THE DEVICE WAS NOT RETURNED. A CONCLUSIVE CAUSE FOR ANY REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THE TREATMENT APPEARS TO BE RELATED TO THE CIRCUMSTANCES OF THE PROCEDURE. THE REPORTED PATIENT EFFECT OF HEMORRHAGE IS LISTED IN THE PERCLOSE PROGLIDE INSTRUCTIONS FOR USE (EIFU), AS POTENTIAL ADVERSE EVENTS OF USE OF THE DEVICE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. B3: DATE OF EVENT: ESTIMATED D4: THE UDI IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. LITERATURE ATTACHMENT ARTICLE, TITLED ¿COMPARISON OF CLINICAL EFFICACY BETWEEN ANGIO-SEAL AND PERCLOSE PROGLIDE VASCULAR CLOSURE DEVICES AFTER FEMORAL ARTERY PUNCTURE HEMOSTASIS.¿

    Description of Event or Problem · 0

    THE ARTICLE COMPARED THE HEMOSTASIS EFFECTS AND SHORT-TERM COMPLICATIONS OF ANGIO-SEAL VASCULAR CLOSURE DEVICE (CLOSURE GROUP) AND PERCLOSE PROGLIDE VASCULAR SUTURE DEVICE (SUTURE GROUP) AFTER FEMORAL ARTERY PUNCTURE AND EXTUBATION. BETWEEN NOVEMBER 2018 AND JUNE 2022, 113 PATIENTS WERE RANDOMLY GROUPED (66 CASES IN THE CLOSURE GROUP AND 47 CASES IN THE SUTURE GROUP). OF THE 47 PATIENTS THAT HAD A PROGLIDE PLACED, MULTIPLE PATIENTS HAD A SMALL AMOUNT OF BLEEDING AT THE ACCESS SITE. ONE PATIENT HAD SEVERE BLEEDING, REQUIRING MANUAL COMPRESSION. THE ARTICLE CONCLUDED BY STATING BOTH THE VASCULAR CLOSURE DEVICES HAVE THE ADVANTAGES OF HIGH SUCCESS RATE OF HEMOSTASIS AND LESS POSTOPERATIVE COMPLICATIONS AND ARE SAFE AND EFFECTIVE HEMOSTASIS METHODS. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED ¿COMPARISON OF CLINICAL EFFICACY BETWEEN ANGIO-SEAL AND PERCLOSE PROGLIDE VASCULAR CLOSURE DEVICES AFTER FEMORAL ARTERY PUNCTURE HEMOSTASIS.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505414 PERCLOSE PROGLIDE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. UNK PROGLIDE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention