BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE¿

    MDR report key: 19986408 · Received August 14, 2024

    Report

    Report Number
    2024168-2024-09619
    Event Type
    Injury
    Date Received
    August 14, 2024
    Date of Event
    July 13, 2024
    Report Date
    October 21, 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

    AN ANALYSIS WAS PERFORMED ON THE RETURNED DEVICE. THE FAILURE TO CYCLE WAS CONFIRMED AS MATERIAL SEPARATION OF THE ANTERIOR CUFF. ANALYSIS OF THE RETURNED DEVICE FOUND A CUFF TAB DETACHMENT. CUFF TABS MEASURE ONE ONE-HUNDREDTH (0.01) OF AN INCH SQUARE AND DUE TO THE EXTREMELY SMALL SIZE; A MISSING CUFF TAB IS NOT VISIBLE WITHOUT MAGNIFICATION AND WOULD NOT BE NOTED BY THE USER. PRODUCTION RECORD AND CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY 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. IN THIS CASE, THE POSTERIOR NEEDLE TIP REMAINED IN THE FOOT POCKET INDICATING A LIKELY NEEDLE DEFLECTION INTERACTION WITH TISSUE PREVENTING THE NEEDLE TIP FROM FULL EJECTION. WHEN THE PLUNGER WAS PULLED, A MATERIAL SEPARATION OF THE ANTERIOR CUFF/NEEDLE OCCURRED LEADING TO THE SUTURE RETRIEVAL ISSUE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. CORRECTIONS: D4 - LOT #: UPDATED FROM 3072041 TO 3102641. D4 - EXPIRATION DATE: UPDATED FROM 8/31/2025 TO 5/31/2025. D4 - PRIMARY UDI NUMBER: UPDATED FROM (B)(4). H4 - DEVICE MFG DATE: UPDATED FROM 7/20/2023 TO 10/26/2023.

    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 THIS WAS A CLOSURE OF AN UNKNOWN VESSEL USING A PROGLIDE DEVICE AFTER AN INTERVENTIONAL PROCEDURE WITH A SMALL-BORE SHEATH. REPORTEDLY, THE SUTURE WAS LOOSE IN THE BODY OF THE DEVICE AND NOT ATTACHED TO THE NEEDLE WHEN THE PLUNGER WAS REMOVED. A NEW PROGLIDE 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
    992357 PERCLOSE PROGLIDE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12673-05 3102641 08717648113154

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention