BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE¿ PROSTYLE¿

    MDR report key: 20866994 · Received December 6, 2024

    Report

    Report Number
    2024168-2024-14380
    Event Type
    Injury
    Date Received
    December 6, 2024
    Date of Event
    November 14, 2024
    Report Date
    February 19, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    UDI-DI
    08717648344039
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LO
    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

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. PRODUCTION RECORD AND CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY DID NOT INDICATE A LOT SPECIFIC QUALITY ISSUE. TWO STERILE/UNUSED DEVICES WITH LOT # 4051342 WERE RETURNED AND WERE SUCCESSFULLY TESTED WITH NO ANOMALIES NOTED. AS SUCH, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED SUTURE SEPARATION. FACTORS THAT MAY CONTRIBUTE TO SUTURE SEPARATION DURING KNOT ADVANCEMENT INCLUDE, BUT ARE NOT LIMITED TO, USER TECHNIQUE (TENSIONING ANGLE NOT COAXIAL) OR SUTURE/ NICK DAMAGE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. CORRECTIONS: H6 - HEALTH EFFECT - IMPACT CODE: CODE 4641 WAS REMOVED AND CODE 2199 WAS ADDED. H6 - MEDICAL DEVICE PROBLEM CODE: CODE 1142 WAS REMOVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS AN ATERIOTOMY CLOSURE OF THE MODERATELY CALCIFIED RIGHT COMMON FEMORAL ARTERY USING A PROSTYLE DEVICE AFTER A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) INTERVENTIONAL PROCEDURE USING A 6F SHEATH. REPORTEDLY, ""AFTER TREATMENT - AFTER PULLING OUT THE BLACK PUSHER STAYED IN THE HANDS W/O THE NEED TO CUT THE SUTURE, THE SUTURES STAYED OUTSIDE - THE FEELING WAS LIKE THE PROCEDURE NEEDS TO BE REDONE" [CUFF MISS]". THE METHOD OF ACHIEVING HEMOSTASIS WAS NOT REPORTED. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THIS WAS AN ARTERIOTOMY CLOSURE OF THE MODERATELY CALCIFIED RIGHT COMMON FEMORAL ARTERY USING A PROSTYLE DEVICE AFTER A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) INTERVENTIONAL PROCEDURE USING A 6F SHEATH. REPORTEDLY, THE SUTURE TORE WHEN ATTEMPTING TO USE THE KNOT PUSHER. THE SUTURE WAS STILL ABLE TO BE 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
    2516081 PERCLOSE¿ PROSTYLE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12773-02 4051342 08717648344039

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention