BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM

    MDR report key: 15320944 · Received August 30, 2022

    Report

    Report Number
    2024168-2022-09249
    Event Type
    Injury
    Date Received
    August 30, 2022
    Date of Event
    May 24, 2022
    Report Date
    October 11, 2022
    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
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT RETURNING FOR EVALUATION. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. USER FACILITY MEDWATCH #MW5111108 ATTACHED.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. 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 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. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.E1/E3: SUBSEQUENT TO FILING THE INITIAL REPORT THE PHYSICIAN'S INFORMATION WAS RECEIVED.

    Description of Event or Problem · 0

    USER FACILITY MEDWATCH REPORT (#5111108) RECEIVED THAT STATES: "FAULTY CATHETER - CATHETER MIGRATED OUT OF THE PA (PULMONARY ARTERY) BECAUSE IT WAS NOT ABLE TO BE LOCKED IN PLACE." SUBSEQUENT TO USER FACILITY MEDWATCH REPORT RECEIVED, CORRECTED INFORMATION WAS PROVIDED BY THE ACCOUNT: IT WAS REPORTED THAT THIS WAS AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY USING A PROSTYLE AFTER A DIAGNOSTIC RIGHT AND LEFT CATHETERIZATION PROCEDURE USING A 6F SHEATH. REPORTEDLY, THE PROSTYLE DEVICE WAS DEPLOYED AND THE FOOTPLATE RETRIEVED [RETRACTED]. THE SUTURE WAS NOT RELEASING FROM THE DEVICE. THE SUTURE WAS MANUALLY CUT TO SUCCESSFULLY REMOVE THE DEVICE. A NON-ABBOT DEVICE AND MANUAL COMPRESSION WERE 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
    147657 PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR 12773-03 2042942 08717648235184

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female Required Intervention