BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 7702235 · Received July 19, 2018

    Report

    Report Number
    2024168-2018-05610
    Event Type
    Injury
    Date Received
    July 19, 2018
    Date of Event
    June 21, 2018
    Report Date
    August 31, 2018
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CORRECTION: LOT NUMBER WAS CORRECTED FROM 8021442 TO 7113041. EVALUATION SUMMARY: ANALYSIS WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED FOOT RETRACTION PROBLEM COULD NOT BE CONFIRMED AS THE FOOT WAS SUCCESSFULLY DEPLOYED AND RETRACTED WITH NO DIFFICULTY NOTED. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO SIMILAR INCIDENTS FROM THIS LOT. THE REPORTED FOOT RETRACTION PROBLEM AND SUBSEQUENT TREATMENT APPEAR TO BE RELATED TO PROCEDURE CIRCUMSTANCE. BASED ON THE INFORMATION REVIEWED, 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 THE INITIAL MEDWATCH REPORT, THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT SUTURE PLACEMENT WITH THREE PROGLIDE DEVICES WERE ATTEMPTED IN A COMMON FEMORAL ARTERY VIA 6FR SHEATH USING THE PRECLOSE TECHNIQUE PRIOR TO AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE. REPORTEDLY, WIDENING OF THE NICK AND SPREAD INCISION USING FORCEPS WAS COMPLETED AND THE ARTERY WAS SUTURED CLOSED TO ACHIEVE HEMOSTASIS. 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 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 OTHER TWO PERCLOSE PROGLIDE DEVICES, REFERENCED, ARE FILED UNDER SEPARATE MEDWATCH MANUFACTURER REPORT REFERENCE NUMBERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF A COMMON FEMORAL ARTERY WAS ATTEMPTED USING THREE PROGLIDE DEVICES AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, AFTER SUTURE DEPLOYMENT, THE LEVER COULD NOT BE PUSHED DOWN COMPLETELY AND FOOT COULD NOT BE RETURNED TO ITS ORIGINAL POSITION WITH ALL THREE PROGLIDE DEVICES. THE METHOD USED TO ACHIEVE HEMOSTASIS WAS NOT REPORTED. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE ENTIRE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545478 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 7113041

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention