BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE¿

    MDR report key: 20545354 · Received October 28, 2024

    Report

    Report Number
    2024168-2024-12618
    Event Type
    Injury
    Date Received
    October 28, 2024
    Date of Event
    September 27, 2024
    Report Date
    January 15, 2025
    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

    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 DEVICE ANALYSIS, THE INVESTIGATION DETERMINED THAT THE REPORTED ISSUE APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. FROM THE RETURNED DEVICE ANALYSIS AN ANTERIOR NEEDLE SCRATCH AND THE CUFF IN THE ANTERIOR POCKET INDICATE AN ANTERIOR NEEDLE TO CUFF MISS OCCURRED. THE CAUSE OF NEEDLE TO CUFF MISS IS GENERALLY RELATED TO USER TECHNIQUE AND/OR AN INTERACTION WITH PATIENT ANATOMY. 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 - LOT # UPDATED FROM 3102641 TO 3100741. D4 - PRIMARY UDI NUMBER UPDATED TO (B)(4).

    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 AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED WITH A PROGLIDE DEVICE AFTER A CORONARY INTERVENTION PROCEDURE USING A 6F SHEATH. REPORTEDLY, THE SUTURE WAS NOT PRESENT WHEN THE PLUNGER WAS REMOVED. MANUAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS. 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
    1020938 PERCLOSE PROGLIDE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12673-05 3100741 08717648113154

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention