BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE¿ PROSTYLE¿

    MDR report key: 21867443 · Received April 18, 2025

    Report

    Report Number
    2024168-2025-04056
    Event Type
    Injury
    Date Received
    April 18, 2025
    Date of Event
    March 28, 2025
    Report Date
    June 4, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    UDI-DI
    08717648344039
    PMA / PMN Number
    P960043
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A VISUAL INSPECTION AND FUNCTIONAL TESTING WERE PERFORMED ON THE RETURNED DEVICE. THE REPORTED OBSTRUCTION OF FLOW WAS NOT CONFIRMED. A NEEDLE TO CUFF MISS AND MATERIAL SEPARATION OF THE CUFF TAB WAS CONFIRMED. 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. ALTHOUGH THE BROKEN CUFF TAB WAS NOT RETURNED, NO ADVERSE PATIENT HEALTH IMPACT HAS BEEN REPORTED. 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 NEEDLE TO CUFF MISS, MATERIAL SEPARATION, AND SUBSEQUENT TREATMENT APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. IN THIS CASE IT IS LIKELY AN INTERACTION WITH PATIENT ANATOMY OR INABILITY TO MAINTAIN POSITION/STABILITY OF THE DEVICE DURING DEPLOYMENT CAUSED THE NEEDLE TO CUFF MISS IN WHERE THE POSTERIOR NEEDLE STRUCK THE CUFF CAUSING THE SEPARATION. 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. CORRECTIONS: D4 - LOT #: UPDATED FROM 3020142 TO 3091942. D4 - EXPIRATION DATE: UPDATED FROM 1/31/2025 TO 8/31/2025. D4 - PRIMARY UDI NUMBER: UPDATED FROM (B)(4). H4 - DEVICE MFG DATE: UPDATED FROM 2/1/2023 TO 9/19/2023. H6 - MEDICAL DEVICE PROBLEM CODE: CODE 2017-USE AFTER EXPIRATION WAS REMOVED.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. H6: MEDICAL DEVICE PROBLEM CODE 2017, USE AFTER EXPIRATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS AN ARTERIOTOMY CLOSURE OF A CALCIFIED RIGHT COMMON FEMORAL ARTERY USING A PROSTYLE DEVICE AFTER AN INTERVENTIONAL TRANSCATHETER ARTERIAL CHEMO EMBOLIZATION PROCEDURE WITH A 5F SHEATH. THE MARKER LUMEN WAS SUCCESSFULLY FLUSHED WITH SALINE PRIOR TO USE. HOWEVER, DURING USE, THERE WAS NO BLOOD FLOW FROM THE MARKER LUMEN. A NEW PROSTYLE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. ADDITIONALLY, IT WAS REPORTED THAT THE PROSTYLE DEVICE WAS EXPIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1747930 PERCLOSE¿ PROSTYLE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12773-02 3091942 08717648344039

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention