BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 8004844 · Received October 25, 2018

    Report

    Report Number
    2024168-2018-08168
    Event Type
    Injury
    Date Received
    October 25, 2018
    Date of Event
    October 4, 2018
    Report Date
    November 27, 2018
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE OTHER FOUR PERCLOSE PROGLIDE DEVICES ARE FILED UNDER SEPARATE MEDWATCH MANUFACTURER REPORT REFERENCE NUMBERS.

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTION: LOT NUMBER CHANGED FROM 8062741 TO 7122141. EVALUATION SUMMARY: VISUAL INSPECTIONS WERE PERFORMED ON THE RETURNED DEVICE. THE REPORTED SUTURE BREAK WAS CONFIRMED AS A NEEDLE TO CUFF MISS/SUTURE RETRIEVAL ISSUE. 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. THE PHYSICIAN IS REPORTED NOT TO BE TRAINED IN THE USE OF THE PROGLIDE DEVICE. IT SHOULD BE NOTED THAT THE PERCLOSE PROGLIDE INSTRUCTIONS FOR USE STATES: THIS DEVICE SHOULD ONLY BE USED BY PHYSICIANS WHO ARE TRAINED IN DIAGNOSTIC AND THERAPEUTIC CATHETERIZATION PROCEDURES AND WHO HAVE BEEN TRAINED BY AN AUTHORIZED REPRESENTATIVE OF ABBOTT VASCULAR. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SUTURE PLACEMENT IN THE AN UNSPECIFIED VESSEL WAS ATTEMPTED WITH FIVE PROGLIDE DEVICES USING THE PRE-CLOSE TECHNIQUE PRIOR TO A PERCUTANEOUS ENDOVASCULAR ANEURYSM REPAIR (PEVAR) INTERVENTIONAL PROCEDURE. REPORTEDLY, A SUTURE BREAK OCCURRED WITH ALL FIVE PROGLIDE DEVICES. THE METHOD OF ACHIEVING HEMOSTASIS WAS NOT REPORTED. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. THE PHYSICIAN IS REPORTEDLY NOT TRAINED IN THE USE OF THE PROGLIDE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845149 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 7122141

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention