BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM

    MDR report key: 18708149 · Received February 14, 2024

    Report

    Report Number
    2024168-2024-01848
    Event Type
    Injury
    Date Received
    February 14, 2024
    Date of Event
    January 26, 2024
    Report Date
    April 4, 2024
    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
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS WAS PERFORMED ON THE RETURNED DEVICE. DIFFICULTY INSERTING THE DEVICE INTO THE ANATOMY COULD NOT BE CONFIRMED AS THE EXACT CONDITIONS ENCOUNTERED BY THE DEVICE DURING THE PROCEDURE COULD NOT BE REPLICATED IN THE TEST ENVIRONMENT. THE REPORTED BENT GUIDE WAS CONFIRMED AS A KINKED SHEATH. THE LOT HISTORY RECORD AND EXCEPTION REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A LOT SPECIFIC QUALITY ISSUE. BASED ON THE RETURNED DEVICE ANALYSIS, A CONCLUSIVE CAUSE COULD NOT BE DETERMINED FOR THE REPORTED DIFFICULTY INSERTING THE DEVICE. THE KINKED SHEATH AND UNEXPECTED MEDICAL INTERVENTION APPEAR TO BE RELATED TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. FACTORS THAT MAY CONTRIBUTE TO INSERTING THE DEVICE INTO THE ANATOMY RESULTING IN A KINKED SHEATH INCLUDE, BUT ARE NOT LIMITED TO, ANATOMICAL CONDITIONS OR AGGRESSIVE MANIPULATION. 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 2121241 TO 2072741.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. THE TWO ADDITIONAL PERCLOSE PROSTYLE DEVICES REFERENCED IN B5 ARE FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY USING THREE PROSTYLE DEVICES AFTER A RENAL ANGIOGRAPHY PROCEDURE WITH A 6F SHEATH. REPORTEDLY, CUFF MISSES [SUTURE RETRIEVAL ISSUES] OCCURRED WITH TWO DEVICES. WHEN ATTEMPTING TO PLACE A THIRD PROSTYLE, THERE WAS RESISTANCE INSERTING THE DEVICE. THE DEVICE WAS REMOVED AND IT WAS FOUND THAT THE GUIDE WAS BENT. A NEW 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
    2157909 PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR 2072741 08717648235184

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention