BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 13337275 · Received January 24, 2022

    Report

    Report Number
    2024168-2022-00792
    Event Type
    Injury
    Date Received
    January 24, 2022
    Date of Event
    November 21, 2021
    Report Date
    January 24, 2022
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    UDI-DI
    08717648013089
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT ESTIMATED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY DID NOT INDICATE A LOT SPECIFIC QUALITY ISSUE. THE REPORTED PATIENT EFFECT OF TISSUE DAMAGE IS LISTED IN THE PERCLOSE PROGLIDE INSTRUCTIONS FOR USE AS A KNOWN ADVERSE EVENT ASSOCIATED WITH USE OF SUTURE MEDIATED CLOSURE DEVICES. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES; HOWEVER, THE TREATMENT APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. 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
    661986 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