BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1951201 · Received January 6, 2011

    Report

    Report Number
    2024168-2011-00056
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    December 13, 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
    CA, US
    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.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED WITHOUT ANY MISSING COMPONENTS. THE DEVICE HAD BEEN PARTIALLY DEPLOYED AND THE FOOT WAS PARKED/FULLY RETRACTED WITH SLACK IN THE LINK MATERIAL NOTED. BOTH THE ANTERIOR AND POSTERIOR CUFFS WERE LOADED WITHIN THE RESPECTIVE FOOT POCKET AND WERE UNDISTURBED. THERE WAS NO DETECTED DEVICE HANDLE ASSEMBLY DAMAGE AND BLOW THROUGH MARKS WERE NOT PRESENT, A RESULT OF NO POSTERIOR CUFF EJECTION FROM THE FOOT. THE PLUNGER WAS COMPLETELY FREE OF THE HANDLE ASSEMBLY AND FULLY INTACT AND UNDAMAGED WITH THE POSTERIOR NEEDLE TIP STILL AFFIXED TO THE POSTERIOR NEEDLE SHANK AND WITH THE COMPLETE UNDAMAGED SUTURE ATTACHED TO THE POSTERIOR NEEDLE TIP. THE DEVICE WAS TESTED FOR THE EJECTION OF THE POSTERIOR NEEDLE TIP FROM THE POSTERIOR NEEDLE SHANK AND NEEDLE TRAJECTORY, NEEDLE DEPTH, AND PUSH MANDREL TRAVEL AND THE RESULTS WERE ACCEPTABLE. NO MANUFACTURING OR QUALITY ISSUES WERE DETECTED. BASED ON THE INVESTIGATION FINDINGS, THE LIKELY ROOT CAUSE FOR THE CONDITION OF THE RETURNED DEVICE IS INCORRECT TECHNIQUE. THE INVESTIGATION DETERMINED THE PLUNGER WAS WITHDRAWN FROM THE HANDLE OF THE DEVICE BEFORE IT WAS PLUNGED OR DISTALLY DEPLOYED. THIS WOULD ACCOUNT FOR THE INTACT CONDITION OF THE POSTERIOR NEEDLE SHANK AND TIP WITH THE SUTURE STILL ATTACHED. 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 IN TRAINING IN THE USE OF THE PERCLOSE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, A DOUBLE CUFF MISS OCCURRED. THE DEVICE WAS REWIRED AND ANOTHER PROGLIDE WAS USED TO ACHIEVED HEMOSTASIS. THERE WAS NO ADVERSE PATIENT SEQUELA. 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 940406H

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention