BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE¿ PROSTYLE¿

    MDR report key: 20791025 · Received November 27, 2024

    Report

    Report Number
    2024168-2024-13229
    Event Type
    Injury
    Date Received
    November 27, 2024
    Date of Event
    October 14, 2024
    Report Date
    January 20, 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
    SF
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED ¿SUTURE WAS NOT PRESENT UPON PULLBACK PLUNGER REMOVAL¿ WAS OBSERVED AS A SUTURE SEPARATION. 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. IT IS LIKELY THAT THE PLUNGER WAS PULLED QUICKLY OR IN A JERKING MOTION SUCH THAT THE SUTURE WAS PULLED FROM THE SWAGE END OF THE POSTERIOR NEEDLE TIP DURING PLUNGER RETRACTION STEP #3. THE REPORTED SUBSEQUENT TREATMENT APPEARS TO BE RELATED TO PROCEDURE CIRCUMSTANCE. 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. B5 - DESCRIBE EVENT OR PROBLEM UPDATED. D4 CORRECTION ¿ LOT NUMBER UPDATED FROM 4052641 TO 4041541.

    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 A VENOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL VEIN WAS ATTEMPTED WITH A PROSTYLE DEVICE RELATIVE TO A PROCEDURE. REPORTEDLY, THE SUTURE WAS NOT PRESENT UPON PULLBACK [PLUNGER REMOVAL]. 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. SUBSEQUENT TO THE INITIALLY FILED REPORT, THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED: THE DEVICE WAS USED AFTER AN ELECTROPHYSIOLOGY PROCEDURE, USING AN 8F SHEATH. - FEMORAL ANGIOGRAM WAS TAKEN PRIOR TO THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A VENOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL VEIN WAS ATTEMPTED WITH A PROSTYLE DEVICE RELATIVE TO A PROCEDURE. REPORTEDLY, THE SUTURE WAS NOT PRESENT UPON PULLBACK [PLUNGER REMOVAL]. 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. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844315 PERCLOSE¿ PROSTYLE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12773-02 4041541 08717648344039

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention