BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 16549564 · Received March 15, 2023

    Report

    Report Number
    2024168-2023-02710
    Event Type
    Injury
    Date Received
    March 15, 2023
    Date of Event
    February 23, 2023
    Report Date
    May 19, 2023
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED SHEATH DAMAGE WAS CONFIRMED. THE REPORTED DIFFICULTY TO REMOVE COULD NOT BE CONFIRMED AS THE EXACT CONDITIONS ENCOUNTERED BY THE DEVICE DURING THE PROCEDURE COULD NOT BE REPLICATED IN THE TEST ENVIRONMENT. A REVIEW OF THE MANUFACTURING RECORDS IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. 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 SUBSEQUENT TREATMENT APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING OF THE DEVICE.D4: LOT NUMBER UPDATED FROM UNKNOWN TO 2112341. H6: MEDICAL DEVICE PROBLEM CODE 1562 REMOVED.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. THE ADDITIONAL PROGLIDE DEVICE REFERENCED WITH REPORTED ISSUE IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 0

    SUBSEQUENTLY TO THE INITIALLY FILED REPORTS, ADDITIONAL INFORMATION WAS PROVIDED. ANALYSIS OF THE RETURNED PROGLIDE DEVICE FOUND A STRETCHED AND KINKED EXIT NOTCH BUT NO SEPARATION AS INITIALLY REPORTED. FOLLOW UP WITH THE ACCOUNT CONFIRMED THAT THE FINDINGS OF THE DEVICE ANALYSIS ARE CONSISTENT WITH WHAT THEY MEANT BY "BROKE AT THE WIRE ENTRY POINT". NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SUTURE PLACEMENT IN THE HEAVILY CALCIFIED LEFT COMMON FEMORAL ARTERY WAS ATTEMPTED WITH A PROGLIDE DEVICE USING THE PRE-CLOSE TECHNIQUE PRIOR TO A TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) INTERVENTIONAL PROCEDURE VIA A 6F SHEATH HOLE. REPORTEDLY DUE TO CALCIUM, FORCE WAS USED TO WITHDRAW THE DEVICE AND IT BROKE AT THE WIRE ENTRY POINT. THE BROKEN PIECE WAS SIMPLY PULLED OUT. THE SUTURES OF TWO NEW PROGLIDE DEVICES WERE SUCCESSFULLY PRE-PLACED. THE SHEATH WAS UPSIZED TO A SHEATH GREATER THAN 10F AND THE TAVI PROCEDURE WAS COMPLETED. THE KNOTS OF THE SUCCESSFULLY PLACED PROGLIDE SUTURES WERE ADVANCED. AT THE END OF THE PROCEDURE, THE PHYSICIAN ALSO USED A NON-ABBOTT DEVICE TO ACHIEVE COMPLETE HEMOSTASIS. THERE WAS NO 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
    758478 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR 2112341

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention