BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE¿ PROSTYLE¿

    MDR report key: 23124669 · Received September 23, 2025

    Report

    Report Number
    2024168-2025-10170
    Event Type
    Injury
    Date Received
    September 23, 2025
    Date of Event
    September 1, 2025
    Report Date
    October 30, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    UDI-DI
    08717648235184
    PMA / PMN Number
    P960043
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL AND FUNCTIONAL ANALYSIS WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED DIFFICULT TO REMOVE GUIDEWIRE AND DIFFICULT TO REMOVE VESSEL COULD NOT BE CONFIRMED AS THE EXACT CONDITIONS ENCOUNTERED BY THE DEVICE DURING THE PROCEDURE COULD NOT BE REPLICATED IN THE TEST ENVIRONMENT. HOWEVER, PERFORMED A GUIDE WIRE PATENCY TEST USING THE NON-ABBOTT 0.034-INCH GUIDE WIRE. THE GUIDEWIRE WAS BACKLOADED WITHOUT RESISTANCE. PERFORMED A GUIDE WIRE PATENCY TEST USING THE 0.038-INCH GUIDE WIRE. THE GUIDEWIRE WAS BACKLOADED WITHOUT RESISTANCE. 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 INFORMATION PROVIDED AND RETURN DEVICE ANALYSIS, A DEFINITIVE CAUSE FOR THE REPORTED DIFFICULTIES COULD NOT BE DETERMINED. FACTORS THAT CONTRIBUTE TO DIFFICULT TO REMOVE GUIDE WIRE, DIFFICULT TO REMOVE FROM VESSEL, INCLUDE, BUT NOT LIMITED TO, PATIENT ANATOMICAL CONDITIONS (OCCLUSION OF THE SHEATH DUE TO EXCESSIVE BLOOD CLOT, PATIENT ARTERY ANATOMY VARIABLES). THE PRE-CLOSE TECHNIQUE WAS NOT USED WHEN CLOSING WITH A SHEATH GREATER THAN 8F. IT SHOULD BE NOTED THAT THE ELECTRONIC PROSTYLE INSTRUCTIONS FOR USE (EIFU), STATES: FOR ACCESS SITES IN THE COMMON FEMORAL ARTERY USING 5F TO 21F SHEATHS. FOR ARTERIAL SHEATH SIZES GREATER THAN 8F, AT LEAST TWO DEVICES AND THE PRE-CLOSE TECHNIQUE ARE REQUIRED. IN THIS CASE, THE IFU DEVIATION WOULD NOT HAVE CONTRIBUTED TO THE REPORTED DIFFICULTIES. THE SUBSEQUENT TREATMENT APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. D4: CORRECTED LOT NUMBER FROM 5060641 TO 5061641. D4: CORRECTED PRIMARY UDI NUMBER FROM (B)(4) TO (B)(4). H4: CORRECTED DEVICE MFG DATE FROM 6/6/2025 TO 6/16/2025

    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: 1494 - INDICATION FOR USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THIS WAS AN ARTERIOTOMY CLOSURE OF A RIGHT COMMON FEMORAL ARTERY USING A PROSTYLE DEVICE AFTER AN INTERVENTIONAL PROCEDURE WITH A 9F SHEATH. REPORTEDLY, AFTER PERFORMING STEP 4, THE GUIDEWIRE WAS ATTEMPTED TO BE REINSERTED AND REMOVE THE PROSTYLE DEVICE. HOWEVER, THE DEVICE WAS UNABLE TO BE REMOVED, AND THE GUIDEWIRE BECAME STUCK. BOTH DEVICES WERE ABLE TO BE REMOVED TOGETHER, AND MANUAL COMPRESSION 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
    581499 PERCLOSE¿ PROSTYLE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12773-03 5061641 08717648235184

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention