BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE¿

    MDR report key: 19784630 · Received July 19, 2024

    Report

    Report Number
    2024168-2024-08599
    Event Type
    Injury
    Date Received
    July 19, 2024
    Date of Event
    June 21, 2024
    Report Date
    September 24, 2024
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    UDI-DI
    08717648113154
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    AN ANALYSIS WAS PERFORMED ON THE RETURNED DEVICE. THE FAILURE TO CYCLE WAS CONFIRMED. PRODUCTION RECORD AND CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED THERE IS NO INDICATION OF A LOT SPECIFIC ISSUE. BASED ON THE REPORTED INFORMATION AND THE OBSERVATIONS FROM THE RETURNED ANALYSIS, THE INVESTIGATION DETERMINED THAT THE REPORTED ISSUE APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. BASED ON OBSERVATIONS FROM THE RETURNED ANALYSIS A POSTERIOR NEEDLE TO CUFF MISS OCCURRED. THE POSTERIOR NEEDLE TIP APPEARS TO HAVE STRIPPED OF THE SUTURE DURING REMOVAL. BASED ON THE RESULTS OF THE COMPLAINT INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. D4 CORRECTION: LOT NUMBER UPDATED FROM 3110741 TO 3102641.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS AN ARTERIOTOMY CLOSURE OF THE LEFT COMMON FEMORAL ARTERY USING A PROGLIDE DEVICE AFTER AN ARTERIOVENOUS MALFORMATION (AVM) EMBOLIZATION WITH A 6F SHEATH. REPORTEDLY, THE SUTURE DID NOT COME OUT WHEN THE HANDLE [PLUNGER] WAS RETRACTED. A NEW 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
    1754762 PERCLOSE PROGLIDE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12673-05 3102641 08717648113154

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention