BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 16637411 · Received March 29, 2023

    Report

    Report Number
    2024168-2023-03163
    Event Type
    Injury
    Date Received
    March 29, 2023
    Date of Event
    March 7, 2023
    Report Date
    May 21, 2023
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED SUTURE SEPARATION WAS CONFIRMED. 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 # UPDATED FROM 2033041 TO 2050441.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY USING A PROGLIDE AFTER A COILING PROCEDURE USING A 6F SHEATH. REPORTEDLY, THE SUTURE BROKE DURING ADVANCEMENT WITH THE SUTURE TRIMMER. MANUAL COMPRESSION 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
    1087554 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR 2050441

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention