BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 13321620 · Received January 21, 2022

    Report

    Report Number
    2024168-2022-00758
    Event Type
    Injury
    Date Received
    January 21, 2022
    Date of Event
    November 22, 2021
    Report Date
    January 21, 2022
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    UDI-DI
    08717648013089
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT ESTIMATED. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION; HOWEVER, THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. THE REPORTED PATIENT EFFECTS OF TISSUE DAMAGE AND DISSECTION ARE LISTED IN THE PERCLOSE PROGLIDE INSTRUCTIONS FOR USE AS A KNOWN ADVERSE EVENTS ASSOCIATED WITH USE OF SUTURE MEDIATED CLOSURE DEVICES. BASED ON THE CASE INFORMATION AND RELATED RECORD REVIEW, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED AND THE TREATMENT APPEARS TO BE RELATED TO THE CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO DESIGN, MANUFACTURE OR LABELING OF THE DEVICE. THE ADDITIONAL PROGLIDE DEVICE REFERENCED IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER. ATTACHMENT: MEDWATCH REPORT # MW5105591.

    Description of Event or Problem · 0

    USER FACILITY MEDWATCH RECEIVED STATES: "ABBOTT PERCLOSE PROGLIDE 6 FR, LOT #1053041, PART #1267303, 2 EVENTS ON SAME PATIENT. IN PATIENT LEFT FEMORAL ARTERY WHEN DEPLOYING THE DEVICE IT "GOT STUCK" IN AN ATTEMPT TO REMOVE IT THE DEVICE BROKE IN THE VESSEL. A CUTDOWN HAD TO BE PERFORMED ON THE PATIENT VESSEL TO RETRIEVE THE BROKEN PIECE AND REPAIR THE VESSEL. ON THE PATIENT'S RIGHT FEMORAL ARTERY, DECREASED BLOOD FLOW TO PATIENTS FOOT NOTED AFTER DEPLOYMENT OF THE DEVICE (RIGHT ILIAC DISSECTION OR ALSO PERCLOSE INJURY) NECESSITATING SURGICAL REPAIR. FDA SAFETY REPORT ID # (B) (4)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1935846 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR 12673-03 1053041 08717648013089

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention