BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2063578 · Received April 19, 2011

    Report

    Report Number
    2024168-2011-02754
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    March 25, 2011
    Report Date
    March 25, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. (B)(4) - INDICATION FOR USE (SHEATH USED GREATER THAN 8 FR). THE DEVICE WAS DISCARDED AT THE FACILITY, THE LOT NUMBER WAS IDENTIFIED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEALED ANY FINDINGS RELEVANT TO THIS REPORT. A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. A DEFINITIVE CAUSE OF THE EVENT COULD NOT BE DETERMINED. IT SHOULD BE NOTED THAT THE REPORTED USE OF THE PROGLIDE DEVICE IN A PATIENT WITH INTRODUCER SHEATH MEASURING 20 FR IS NOT CONSISTENT WITH THE INSTRUCTIONS FOR USE (IFU); UNDER INDICATIONS FOR USE READS: THE PERCLOSE PROGLIDE 6F SYSTEM IS INDICATED FOR THE PERCUTANEOUS DELIVERY OF SUTURE FOR CLOSING THE COMMON FEMORAL ARTERY ACCESS SITE OF PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL CATHETERIZATION PROCEDURES USING 5F TO 8F SHEATHS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN, TRAINED IN THE USE OF THE PROGLIDE DEVICE, ATTEMPTED ARTERIOTOMY CLOSURE OF THE LEFT COMMON FEMORAL ARTERY AFTER AN ABDOMINAL AORTIC ANEURYSM (AAA) PROCEDURE IN A 20 FR SHEATH SETTING. REPORTEDLY, THE SUTURE WAS DEPLOYED, HOWEVER, THE SUTURE GOT CAUGHT ON THE BACK PART OF THE DEVICE AND THE DEVICE WAS NOT ABLE TO BE REMOVED. THE PHYSICIAN REOPENED AND CLOSED THE LEVER TO MAKE SURE THE LEVER WAS FULLY DOWN IN AN UNSUCCESSFUL ATTEMPT TO FREE THE DEVICE. THE PHYSICIAN REMOVED THE STUCK SUTURE, AND THE DEVICE, AND WITH THE GUIDE WIRE STILL IN PLACE ANOTHER PROGLIDE WAS SUCCESSFULLY DEPLOYED ACHIEVING HEMOSTASIS. THERE WERE NO ADVERSE PATIENT EFFECTS. A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OF LESS THAN 30 MINUTES WAS REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 010096H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention