BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE¿

    MDR report key: 19626084 · Received June 27, 2024

    Report

    Report Number
    2024168-2024-07723
    Event Type
    Injury
    Date Received
    June 27, 2024
    Date of Event
    June 5, 2024
    Report Date
    August 30, 2024
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL ANALYSIS WAS PERFORMED ON THE RETURNED DEVICE AND THE REPORTED SUTURE DETACHMENT WAS OBSERVED AS A NEEDLE TO CUFF MIS. PRODUCTION RECORD AND CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. THE INVESTIGATION DETERMINED THAT THE REPORTED DIFFICULTIES AND SUBSEQUENT TREATMENT APPEAR TO BE RELATED TO AN INTERACTION OF THE DEVICE WITH PATIENT ANATOMY OR INABILITY TO MAINTAIN POSITION/STABILITY OF THE DEVICE DURING DEPLOYMENT DUE TO CIRCUMSTANCES OF THE PROCEDURE. BASED ON THE REPORTED INFORMATION AND 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 3091441 TO 3052342. D4 - EXPIRATION DATE: UPDATED FROM 07/31/2025 TO 03/31/2025. D4 - PRIMARY UDI NUMBER: UPDATED FROM (B)(4) TO (B)(4). H4 - DEVICE MFG DATE: UPDATED FROM 09/14/2023 TO 05/23/2023.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. THE ADDITIONAL PROGLIDE DEVICES REFERENCED IN B5 ARE FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE PREVIOUSLY FILED MEDWATCH REPORTS, THE RETURNED DEVICE ANALYSIS NOTED: A POSTERIOR FOOT SEPARATION WAS FOUND DURING EVALUATION OF THE RETURNED DEVICE. IT WAS CONFIRMED THAT THE FOOT SEPARATION OCCURRED WHEN THE PHYSICIAN MANIPULATED THE DEVICE AFTER USE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THIS WAS AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY USING THE PRE-CLOSE TECHNIQUE VIA A 6F SHEATH HOLE PRIOR TO A THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) INTERVENTIONAL PROCEDURE. REPORTEDLY, A CUFF MISS [SUTURE RETRIEVAL ISSUE] WAS NOTICED WITH ONE PROGLIDE DEVICE. A SUTURE BREAK OCCURRED WITH FIVE PROGLIDE DEVICES. THE SUTURES OF TWO NEW PROGLIDE DEVICES WERE SUCCESSFULLY PRE-PLACED. THE SHEATH WAS UPSIZED TO AN 18F SHEATH AND THE TEVAR PROCEDURE WAS COMPLETED. HEMOSTASIS WAS ACHIEVED WITH THE PRE-PLACED PROGLIDE SUTURES. THERE WAS NO REPORTED 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
    1751305 PERCLOSE PROGLIDE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12673-05 3052342

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention