BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 7846996 · Received September 5, 2018

    Report

    Report Number
    2024168-2018-06885
    Event Type
    Injury
    Date Received
    September 5, 2018
    Date of Event
    August 15, 2018
    Report Date
    March 27, 2019
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    UDI-DI
    08717648013089
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CORRECTION: LOT NUMBER UPDATED FROM 8022842 TO 8032442. CORRECTION: DEVICE STATUS CHANGED FROM NOT RETURNING TO RETURNED. REPORT SOURCE CORRECTION: REMOVE USER FACILITY. THE OTHER PROGLIDE DEVICE REFERENCED IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER. EVALUATION SUMMARY: VISUAL INSPECTIONS WERE PERFORMED ON THE RETURNED DEVICE. THE REPORTED SUTURE BREAK WAS NOT CONFIRMED. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES; HOWEVER, THE TREATMENT APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING OF THE DEVICE.

    Description of Event or Problem · 0

    SUBSEQUENT TO FILING OF THE INITIAL MEDWATCH REPORT ADDITIONAL INFORMATION WAS RECEIVED. "THE FIRST [PROGLIDE] DEVICE THE SURGEON DEPLOYED OVER THE WIRE SO WE REMOVED THE SUTURE AND USED A SECOND [PROGLIDE] DEVICE WHICH IS WHERE THE SUTURE SNAPPED." NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO INTERACTION OF THE DEVICE WITH PATIENT ANATOMY DUE TO CIRCUMSTANCES OF THE PROCEDURE AND THE SUBSEQUENT TREATMENT APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. 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 AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PROGLIDE DEVICE WITH A 7F SHEATH AFTER A RENAL ANGIOPLASTY AND STENTING INTERVENTIONAL PROCEDURE. REPORTEDLY, A SUTURE BREAK OCCURRED DURING TIGHTENING OF THE PROGLIDE KNOT. MANUAL ARTERIAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION PROVIDED. SUBSEQUENTLY, (B)(6) CLINICAL CONSUMER REPORT ((B)(4)) RECEIVED STATING: [THE PROGLIDE DEVICE] "BROKE PRIOR TO FULL USE WHEN IT CAME OUT OF THE SHEATH IT SNAPPED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689507 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 8032442 08717648013089

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH:7FHEPARIN| SHEATH:7FHEPARIN