BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 12537217 · Received September 27, 2021

    Report

    Report Number
    2024168-2021-08652
    Event Type
    Injury
    Date Received
    September 27, 2021
    Date of Event
    September 7, 2021
    Report Date
    January 13, 2022
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED KNOT ADVANCEMENT ISSUE COULD NOT BE CONFIRMED AS THE SUTURE WAS NOT RETURNED AND THE EXACT CONDITIONS ENCOUNTERED BY THE DEVICE DURING THE PROCEDURE COULD NOT BE REPLICATED IN THE TEST ENVIRONMENT. A REVIEW OF THE MANUFACTURING RECORDS 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. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. D4 - LOT NO UPDATED FROM 1012642 TO 1060142; EXPIRATION DATE CORRECTED BASED ON UPDATE LOT NUMBER. H4: CORRECTION OF DEVICE MANUFACTURE DATE BASED ON UPDATED LOT NUMBER.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE ADDITIONAL PROGLIDE DEVICE REFERENCED IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THIS WAS AN ARTERIOTOMY CLOSURE OF A COMMON FEMORAL ARTERY USING THE PRE-CLOSE TECHNIQUE VIA A 6F SHEATH HOLE PRIOR TO A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) INTERVENTIONAL PROCEDURE. THE SUTURES OF TWO PROGLIDE DEVICES WERE SUCCESSFULLY PRE-PLACED. THE SHEATH WAS UPSIZED TO AN 18F SHEATH AND THE TAVR PROCEDURE WAS COMPLETED. WHEN USING THE KNOT PUSHER TO ADVANCE THE KNOT OF THE PROGLIDE DEVICES, THE KNOTS DID COULD NOT BE ADVANCED AND HEMOSTASIS WAS NOT ACHIEVED. CUT DOWN SURGERY WAS PERFORMED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1429747 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR 1060142

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention 18F SHEATH| HEPARIN| PROGLIDE SUTURE X1