BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1974111 · Received January 31, 2011

    Report

    Report Number
    2024168-2011-00555
    Event Type
    Injury
    Date Received
    January 31, 2011
    Date of Event
    December 23, 2010
    Report Date
    January 6, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 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 TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF A SMALL (3MM), CALCIFIED COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, 11 DAYS POST PROCEDURE THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR LEG PAIN AND IT WAS FOUND THAT THE PROGLIDE SUTURE HAD BEEN STITCHED TO THE POSTERIOR WALL. USING A CONTRALATERAL APPROACH, A BALLOON CATHETER WAS USED TO CREATE A SMALL CHANNEL THROUGH THE BLOCKED ARTERIES DISTAL TO THE COMMON FEMORAL ARTERY. THE PATIENT STILL HAD NO DISTAL PULSES AND REMAINED IN THE HOSPITAL. LOVENOX WAS ADMINISTERED TO TREAT THROMBUS AND PLAQUE. THE PATIENT'S FOOT BECAME WARM WITHIN A COUPLE OF DAYS AND WAS DISCHARGED AFTER 3 DAYS IN THE HOSPITAL. THERE WAS NO ADVERSE PATIENT SEQUELA 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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R