BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 18142535 · Received November 15, 2023

    Report

    Report Number
    2024168-2023-12703
    Event Type
    Injury
    Date Received
    November 15, 2023
    Date of Event
    October 25, 2023
    Report Date
    December 29, 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
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR ANALYSIS. THE MECHANICAL JAM WAS CONFIRMED BASED ON THE CONDITION OF THE DEVICE. 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 INDICATION OF A LOT SPECIFIC PRODUCT QUALITY ISSUE. THE ROOT CAUSE OF THE REPORTED DIFFICULTIES CANNOT BE DETERMINED. THE SUBSEQUENT TREATMENT IS RELATED TO CIRCUMSTANCES OF THE PROCEDURE. BASED ON THE RETURNED DEVICE ANALYSIS, THE CAUSE OF THE REPORTED DIFFICULTIES APPEAR TO BE BECAUSE STEP #2 WAS ATTEMPTED PRIOR TO STEP 1; HOWEVER, THIS CANNOT BE CONFIRMED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. D4: LOT NUMBER UPDATED FROM 3081841 TO 3071443.

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT ESTIMATED. MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. THE ADDITIONAL PROGLIDE DEVICES REFERENCED IN B5 ARE FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS A VENOTOMY CLOSURE OF AN UNKNOWN VESSEL USING A PROGLIDE AFTER A ELECTROPHYSIOLOGY ABLATION INTERVENTIONAL PROCEDURE. REPORTEDLY A CUFF MISS [SUTURE RETRIEVAL ISSUE] OCCURRED. ANOTHER PROGLIDE WAS USED BUT THE SAME OCCURRED. ANOTHER PROGLIDE WAS USED BUT THE PLUNGER WAS UNABLE TO BE DEPRESSED. ANOTHER PROGLIDE 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
    292199 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR 3071443 08717648013089

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention