BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 12285188 · Received August 5, 2021

    Report

    Report Number
    2024168-2021-06882
    Event Type
    Injury
    Date Received
    August 5, 2021
    Date of Event
    November 11, 2020
    Report Date
    August 5, 2021
    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
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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 IDENTIFIED NO SIMILAR INCIDENTS FROM THIS LOT. 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. (B)(4).

    Description of Event or Problem · 1

    USER FACILITY MEDWATCH REPORT RECEIVED THAT STATES: "DURING SURGICAL PROCEDURE, PERCLOSE PROGLIDE SUTURE MEDIATED CLOSURE SYSTEM DID NOT DEPLOY CORRECTLY. ANOTHER DEVICE WAS AVAILABLE AND USED, NO HARM TO PATIENT, DEVICE REF#12673-03, LOT#0061341."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1176741 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR 12673-03 0061341 08717648013089

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Required Intervention