BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 7970292 · Received October 16, 2018

    Report

    Report Number
    2024168-2018-07940
    Event Type
    Injury
    Date Received
    October 16, 2018
    Date of Event
    September 24, 2018
    Report Date
    November 16, 2018
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE TWO ADDITIONAL PERCLOSE PROGLIDE DEVICES REFERENCED ARE BEING FILED UNDER SEPARATE MEDWATCH MANUFACTURER REPORT NUMBERS.

    Additional Manufacturer Narrative · 1

    INTERNAL FILE NUMBER - (B)(4). CORRECTION: LOT NUMBER WAS UPDATED FROM 8010241 TO 8071643. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED SUTURE DETACHMENT WAS 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 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. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SUTURE PLACEMENT WITH THREE PROGLIDE DEVICES WERE ATTEMPTED IN THE LEFT COMMON FEMORAL ARTERY VIA 16FR SHEATH USING THE PRECLOSE TECHNIQUE PRIOR TO A "CT" PROCEDURE. REPORTEDLY, WHEN THE PLUNGER WAS REMOVED, THE THREADS (SUTURES) BROKE WITH THE THREE PROGLIDE DEVICES. THE ARTERY WAS SUCCESSFULLY CLOSED SURGICALLY. AN ADDITIONAL PROGLIDE DEVICE WAS REMOVED FROM THE BOX; HOWEVER, WAS NOT USED AS THE THREADS (SUTURES) WERE "OUTSIDE" THE DEVICE. THE DEVICE WAS NOT USED IN THE PATIENT ANATOMY. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE ENTIRE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT SUTURE PLACEMENT WITH THREE PROGLIDE DEVICES WERE ATTEMPTED IN THE MILDLY CALCIFIED LEFT COMMON FEMORAL ARTERY VIA 6FR SHEATH USING THE PRECLOSE TECHNIQUE PRIOR TO A TRANSCATHETER AORTIC VALVE IMPLANTATION PROCEDURE. THE ARTERY WAS CLOSED VIA SURGERY WITH "CLASSIC WAY SUTURING". NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809327 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 8071643

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention SHEATH: 16FRHEPARIN, PROTAMINE