BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM

    MDR report key: 16631664 · Received March 28, 2023

    Report

    Report Number
    2024168-2023-03127
    Event Type
    Injury
    Date Received
    March 28, 2023
    Date of Event
    March 10, 2023
    Report Date
    May 5, 2023
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    UDI-DI
    08717648235184
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED NEEDLE TO CUFF MIS WAS CONFIRMED. THE REPORTED DIFFICULT OR DELAYED ACTIVATION (DIFFICULT TO DEPLOY) PLUNGER COULD NOT BE CONFIRMED DUE TO COMPONENT NOT RETURNED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A LOT SPECIFIC QUALITY ISSUE. TWO UNUSED STERILE DEVICES FROM A DIFFERENT LOT (2102842) WERE RETURNED AND TESTING WAS SUCCESSFULLY PERFORMED WITH NO ANOMALIES NOTED. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES. FACTORS THAT CONTRIBUTE TO PLUNGER DEPLOYMENT ISSUE AND NEEDLE TO CUFF MISS, INCLUDE, BUT NOT LIMITED TO, NEEDLE DEFLECTION DURING PLUNGER DEPLOYMENT DUE TO INTERACTION WITH PATIENT ANATOMY (HUMAN TISSUE, CALCIFIED FEMORAL VESSEL, ETC.) OR FAILURE TO MAINTAIN A STABLE POSITION OF THE DEVICE WITH RESPECT TO THE TISSUE TRACT. THE TREATMENT APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    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 PERCLOSE PROSTYLE DEVICES WITH REPORTED ISSUES REFERENCED ARE FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SUTURE PLACEMENT IN THE MILDLY CALCIFIED RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED WITH THREE PROSTYLE DEVICES USING THE PRE-CLOSE TECHNIQUE VIA A 14F SHEATH HOLE PRIOR TO A STENT GRAFT INTERVENTIONAL PROCEDURE. REPORTEDLY, THE PLUNGER WAS MORE DIFFICULT TO DEPLOY AND A CUFF MISS [SUTURE RETRIEVAL ISSUE] OCCURRED. THIS OCCURRED WITH ALL THREE DEVICES. THE SUTURES OF TWO NEW PROSTYLE DEVICES WERE SUCCESSFULLY PRE-PLACED. THE USE OF A 14F SHEATH WAS CONTINUED AND THE STENT GRAFT PROCEDURE WAS COMPLETED. HEMOSTASIS WAS ACHIEVED WITH THE PRE-PLACED PROSTYLE SUTURES. THERE WAS NO REPORTED 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
    555722 PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR 12773-03 2090941 08717648235184

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention