BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 16052362 · Received December 27, 2022

    Report

    Report Number
    2024168-2022-13103
    Event Type
    Injury
    Date Received
    December 27, 2022
    Date of Event
    November 7, 2022
    Report Date
    February 28, 2023
    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
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED UNKNOWN FAILURE WAS CONFIRMED AS A FOOT SEPARATION. A REVIEW OF THE MANUFACTURING RECORDS REVEALED NO MANUFACTURING NONCONFORMITIES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A LOT SPECIFIC QUALITY ISSUE. 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. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. D4- LOT# UPDATED FROM 2092841 TO 2091641.

    Additional Manufacturer Narrative · 0

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE ADDITIONAL PROGLIDE DEVICES ARE BEING FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS A VESSEL CLOSURE OF AN UNKNOWN VESSEL USING THREE PROGLIDE DEVICES RELATIVE TO AN UNKNOWN PROCEDURE. REPORTEDLY, AN UNKNOWN FAILURE WAS NOTICED. AN UNKNOWN METHOD WAS USED TO ACHIEVE HEMOSTASIS. NO ADDITIONAL INFORMATION WAS PROVIDED. SUBSEQUENT TO PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED: EVALUATION OF THE THREE PROGLIDE DEVICES RETURNED FOUND A POSTERIOR FOOT BREAK ON ALL 3 DEVICES. THE LOCATION OF THE DETACHED FEET IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS A VESSEL CLOSURE OF AN UNSPECIFIED VESSEL USING THREE PROGLIDE DEVICES RELATIVE TO AN UNKNOWN PROCEDURE. REPORTEDLY, AN UNKNOWN FAILURE WAS NOTICED. AN UNKNOWN METHOD WAS USED TO ACHIEVE HEMOSTASIS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447570 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR 12673-03 2091641 08717648013089

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention