BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2023887 · Received March 18, 2011

    Report

    Report Number
    2024168-2011-01818
    Event Type
    Injury
    Date Received
    March 18, 2011
    Date of Event
    February 23, 2011
    Report Date
    February 23, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    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. USE IN A PATIENT WITH SEVERE PERIPHERAL VASCULAR DISEASE. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN IN-TRAINING IN THE USE OF THE PERCLOSE PROGLIDE DEVICE ACHIEVED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PERIPHERAL ANGIOGRAPHIC PROCEDURE. REPORTEDLY, AFTER ACHIEVING HEMOSTASIS WITH THE SUTURE, THE PULSES OF THE LOWER LIMB WERE DIMINISHED. ARTERIAL ACCESS WAS OBTAINED CONTRALATERALLY AND AN ANGIOGRAM REVEALED THE DIAMETER OF THE ARTERY WAS NARROWED FROM 5MM BEFORE THE PROCEDURE TO 1 MM AFTER THE PROCEDURE FROM AN UNSPECIFIED MATERIAL. IT COULD NOT BE DETERMINED WHAT SPECIFICALLY CAUSED THE OCCLUSION. THE ARTERY WAS TREATED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TO FULLY RESTORE BLOOD FLOW, WHICH SUBSEQUENTLY RESTORED PALPABLE PULSES IN THE LOWER LIMB. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention