BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE¿

    MDR report key: 25148751 · Received May 12, 2026

    Report

    Report Number
    2024168-2026-01924
    Event Type
    Injury
    Date Received
    May 12, 2026
    Date of Event
    January 1, 2021
    Report Date
    May 12, 2026
    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. CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. A REVIEW OF THE PRODUCTION RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBER WERE NOT PROVIDED. BASED ON THE CASE INFORMATION, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS OF PAIN, NUMBNESS, SWELLING/EDEMA AND OCCLUSION, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. IN THIS CASE, IT IS UNKNOWN IF THE REPORTED IFU DEVIATION CONTRIBUTED TO THE REPORTED PATIENT EFFECT. IT SHOULD BE NOTED THAT THE ELECTRONIC PERCLOSE PROGLIDE INSTRUCTIONS FOR USE (EIFU) STATES: THE PERCLOSE PROGLIDE SMC AND REPAIR SYSTEM IS INDICATED FOR THE PERCUTANEOUS DELIVERY OF SUTURE FOR CLOSING THE COMMON FEMORAL ARTERY AND VEIN ACCESS SITES OF PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL CATHETERIZATION PROCEDURES. THE REPORTED UNEXPECTED MEDICAL INTERVENTION WAS LIKELY RELATED TO CASE CIRCUMSTANCES. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. B3 - DATE OF EVENT: ESTIMATED D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. H6: MEDICAL DEVICE PROBLEM CODE 1494 - INCORRECT ANATOMY. LITERATURE ATTACHMENT: ARTICLE, TITLED "OUTCOMES OF SUTURE-MEDIATED VASCULAR CLOSURE DEVICE IN THE CLOSURE OF LEFT BRACHIAL ARTERY ACCESS SITE AFTER THORACIC ENDOVASCULAR AORTIC REPAIR".

    Description of Event or Problem · 0

    THE PURPOSE OF THIS ARTICLE WAS TO EVALUATE THE FEASIBILITY AND SAFETY OF THE SUTURE-MEDIATED VASCULAR CLOSURE DEVICE IN THE CLOSURE OF THE LEFT BRACHIAL ARTERY ACCESS SITE AFTER THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR). BETWEEN (B)(6) 2021 TO (B)(6) 2023, 27 PATIENTS, WHOSE BRACHIAL ARTERY WAS OVER 5 MM, HAD A PROGLIDE USED TO CLOSE THE ACCESS SITE. REPORTEDLY, THE PROGLIDE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO NUMBNESS, PAIN, SWELLING, AND OCCLUSION REQUIRING REINTERVENTION. THE ARTICLE CONCLUDED BY STATING IT IS EFFECTIVE TO USE THE SUTURE-MEDIATED VASCULAR CLOSURE IN THE LEFT BRACHIAL ARTERY ACCESS SITE AFTER TEVAR, AND THE LONG-TERM EFFECT IS SATISFACTORY. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED "OUTCOMES OF SUTURE-MEDIATED VASCULAR CLOSURE DEVICE IN THE CLOSURE OF LEFT BRACHIAL ARTERY ACCESS SITE AFTER THORACIC ENDOVASCULAR AORTIC REPAIR".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217605 PERCLOSE PROGLIDE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. UNK PROGLIDE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention