BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1953273 · Received January 7, 2011

    Report

    Report Number
    2024168-2011-00166
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    December 14, 2010
    Report Date
    December 16, 2010
    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
    HEALTH PROFESSIONAL

    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. THE SECOND AND THIRD PERCLOSE PROGLIDE (12673-05/940266H), ARE EACH BEING FILED UNDER A SEPARATE MFR#.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE FOUND THE LINK WAS BROKE AT THE POSTERIOR CUFF. A LINK DETACHMENT WILL RESULT IN A FAILURE TO RETRIEVE THE SUTURE DURING PLUNGER RETRACTION AND CAN APPEAR VERY SIMILAR TO THE REPORTED CUFF MISS. BASED ON THIS FINDING THE REPORTED EXPERIENCE IS CONFIRMED. THE DEVICE WAS PARTIALLY DEPLOYED WITH BLOOD PRESENT IN THE DEVICE. THE POSTERIOR CUFF WAS CAPTURED AND ATTACHED TO THE NEEDLE TIP BUT THE PLUNGER W/ANTERIOR NEEDLE TIP WAS NOT RETURNED. THE SUTURE BEARING, BRIDGE AND GUIDE WERE EXAMINED AND FOUND TO BE NORMAL FOR A DEPLOYED DEVICE AND NOT A CONTRIBUTING FACTORY IN THE EVENT. SOME OF THE CAUSES FOR A LINK BREAK AS OUTLINE IN THE USER TROUBLE SHOOTING AND TRAINING GUIDE ARE AS FOLLOWS: EXCESSIVE FORCE DURING PLUNGER REMOVAL, JERKY MOTION OR A SIDE WALL STICK. GENTLY REMOVING THE PLUNGER DURING THE FIRST 2 CM CAN REDUCE THE LINK BREAKAGE DUE TO THESE CAUSES. BASED ON THE ANALYSIS OF THE DEVICE THE CAUSE FOR THE EVENT IS RELATED TO THE OPERATIONAL CONTEXT IN DURING USE OF THE DEVICE. NO MANUFACTURING OR QUALITY INSPECTION ISSUE WAS DETECTED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, WHEN THE PLUNGER WAS WITHDRAWN, NO SUTURE WAS RETRIEVED. THE SAME PRODUCT EXPERIENCE OCCURRED FOR TWO OTHER PROGLIDE DEVICES. A NON- ABBOTT DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT 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 940266H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention