BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 16765654 · Received April 18, 2023

    Report

    Report Number
    2024168-2023-03983
    Event Type
    Injury
    Date Received
    April 18, 2023
    Date of Event
    March 27, 2023
    Report Date
    June 28, 2023
    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

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.

    Additional Manufacturer Narrative · 0

    ANALYSIS WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED SUTURE DETACHMENT 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 LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY DID NOT INDICATE A LOT SPECIFIC QUALITY ISSUE. A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTY COULD NOT BE DETERMINED. FACTORS THAT MAY CONTRIBUTE TO SUTURE DETACHMENT DURING KNOT ADVANCEMENT MAY INCLUDE, BUT ARE NOT LIMITED TO, PUSHING MORE THAN TENSIONING THE RAIL LIMB, THE LEVER DEPLOYED EARLY OR EXCESSIVE SUTURE TENSION. THE SUBSEQUENT TREATMENT APPEARS TO BE RELATED TO PROCEDURE CIRCUMSTANCE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING OF THE DEVICE. D4- LOT # UPDATED FROM 2042741. TO 2011742 .

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS AN ARTERIOTOMY CLOSURE OF A COMMON FEMORAL ARTERY USING A PROGLIDE DEVICE AFTER A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) INTERVENTIONAL PROCEDURE USING A 6F SHEATH. REPORTEDLY, A SUTURE BREAK OCCURRED WHEN ADVANCING THE KNOT. ANOTHER PROGLIDE DEVICE WAS USED TO ACHIEVE 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
    1033193 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR 2011742

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention