BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1912058 · Received December 1, 2010

    Report

    Report Number
    2953144-2010-03051
    Event Type
    Injury
    Date Received
    December 1, 2010
    Date of Event
    November 5, 2010
    Report Date
    November 9, 2010
    Manufacturer
    AV-REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. (B)(4): DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PROGLIDE DEVICE ACHIEVED ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, ON (B)(6) 2010, THE PATIENT RETURNED TO THE PHYSICIAN WITH PARESTHESIA TO THE ANTERIOR PORTION OF THE RIGHT THIGH. THE PATIENT HAD NO POPLITEAL PULSE; HOWEVER, DID HAVE PULSES IN HER FEET. THE ARTERY-BRACHIAL INDEX (ABI) WAS .05 REFERRED TO BY THE PHYSICIAN AS "SHORT VOCAL OCCLUSION". THE PATIENT WAS SET UP TO SEE A THE VASCULAR SURGEON FOR AN ANGIOGRAM ON (B)(6) 2010, BUT CALLED ON (B)(6) 2010 AND CANCELED THE APPOINTMENT. TO DATE THE PATIENT HAS NOT RESCHEDULED THE APPOINTMENT. 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-REDWOOD CITY

    Patients

    Seq Age Sex Outcome Treatment
    1 Other