BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 19008327 · Received March 29, 2024

    Report

    Report Number
    2024168-2024-03931
    Event Type
    Injury
    Date Received
    March 29, 2024
    Date of Event
    January 1, 2018
    Report Date
    April 11, 2024
    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

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. B3 - DATE OF EVENT WAS ESTIMATED. THE PATIENTS WERE ENROLLED BETWEEN JANUARY 2018 AND APRIL 2022. D4- THE UDI IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. H6- MEDICAL DEVICE PROBLEM CODE 1494 CLARIFIER: INDICATION FOR USE.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. LOT HISTORY RECORD (LHR) AND CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) REVIEWS COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. THE PRE-CLOSE TECHNIQUE WAS NOT USED WITH A SHEATH GREATER THAN 8F. THE ELECTRONIC PROGLIDE INSTRUCTIONS FOR USE (IFU) STATES: FOR ACCESS SITES IN THE COMMON FEMORAL ARTERY USING 5F TO 21F SHEATHS. FOR SHEATH SIZES GREATER THAN 8F, AT LEAST TWO DEVICES AND THE PRE-CLOSE TECHNIQUE ARE REQUIRED. BASED ON THE INFORMATION REPORTED THROUGH THE RESEARCH ARTICLE, A CONCLUSIVE CAUSE FOR THE REPORTED FAILURE TO ACHIEVE HEMOSTASIS AND INSUFFICIENT INFORMATION COULD NOT BE DETERMINED. THE PATIENT EFFECTS OF HEMORRHAGE AND VASCULAR DISSECTION ARE LISTED IN THE ELECTRONIC PROGLIDE IFU AS POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE USE OF THE DEVICE. A DEFINITIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THE REPORTED UNEXPECTED MEDICAL INTERVENTION AND SURGICAL INTERVENTION WERE LIKELY RELATED TO CASE CIRCUMSTANCES. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 0

    THE AIM OF THE ARTICLE WAS TO COMPARE THE OUTCOMES OF THE PERCUTANEOUS METHOD USING PROGLIDE DEVICES COMPLEMENTED BY AN ANGIOSEAL WITH THE SURGICAL METHOD FOR MINIMAL INVASIVE CARDIAC SURGERY. A TOTAL OF 524 PATIENTS WERE PART OF THE STUDY BETWEEN JANUARY 2018 AND APRIL 2022. 88 PATIENTS WERE CANNULATED USING THE PERCUTANEOUS METHOD FROM JUNE 2020 AND 436 PATIENTS WERE CANNULATED USING THE SURGICAL METHOD. THE ARTICLE MENTIONS THAT ONE PROGLIDE WAS PRE-PLACED IN THE ARTERIAL CANNULA ACCESS SITE. PATIENTS WITH RESIDUAL MILD OOZING AND THOSE WITH A 16F CANNULA, HAD MANUAL COMPRESSION AND A SUBCUTANEOUS U-STITCH APPLIED WHEN REQUIRED AFTER CLOSURE WITH THE PROGLIDE. FOR PATIENTS WITH A MODERATE OR MORE THAN MODERATE BLEEDING, A 6F OR 8F ANGIOSEAL DEVICE WAS PLACED DEPENDING ON THE SEVERITY OF THE BLEEDING. A U-STITCH WAS THEN APPLIED AND A PRESSURE BANDAGE FOR 4 TO 6 HOURS IF NEEDED FOLLOWING THE PROCEDURE. GROIN COMPLICATIONS IN THE SURGICAL GROUP WAS FOUND TO BE 4% AND GROIN COMPLICATIONS IN THE PERCUTANEOUS GROUP WAS FOUND TO BE 0%. IN THE PERCUTANEOUS GROUP, THE PERCUTANEOUS APPROACH WAS NEARLY 100% SUCCESSFUL. SURGICAL INTERVENTION WAS REQUIRED IN THE CASE OF DEVICE FAILURE. DISSECTION WAS ALSO NOTED IN BOTH GROUPS. THE ARTICLE CONCLUDED THAT THE PERCUTANEOUS CANNULATION APPROACH IS A SAFE TECHNIQUE FOR PATIENT'S UNDERGOING MINIMAL INVASIVE CARDIAC SURGERY. IT MINIMIZES POSTOPERATIVE GROIN COMPLICATIONS WITH NO OBVIOUS NEGATIVE IMPACT ON OUTCOMES. DETAILS ARE LISTED IN THE ARTICLE, TITLED "PERCUTANEOUS VERSUS OPEN SURGICAL CANNULATION FOR MINIMAL INVASIVE CARDIAC SURGERY; IMMEDIATE POSTPROCEDURAL OUTCOME ANALYSIS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2592159 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention