BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1912053 · Received December 1, 2010

    Report

    Report Number
    2953144-2010-03050
    Event Type
    Injury
    Date Received
    December 1, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 10, 2010
    Manufacturer
    AV-REDWOOD CITY
    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

    IT WAS INITIALLY REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS. SUBSEQUENT INFORMATION REVEALED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. THE LOT NUMBER WAS NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED.(B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. (B)(4) - MORBID OBESITY. (B)(4): DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. DEVICE #1 - PROGLIDE (PART #12673-03; LOT #UNK), ARE BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE STARCLOSE SE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, THE DEVICE COULD NOT BE INSERTED THROUGH THE SHEATH. THE STARCLOSE SE SYSTEM WAS REMOVED AND MANUAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, A KINK WAS FOUND IN THE DISTAL END OF THE SHEATH. THE GUIDE WIRE WAS DIFFICULT TO ADVANCE INTO THE PROGLIDE AND AFTER CONTINUALLY TRYING TO ADVANCE THE GUIDE WIRE, THE GUIDE WIRE PUNCTURING A HOLE THROUGH THE SHEATH CREATING ITS OWN LUMEN. THE TIP OF THE PROGLIDE FOLDED BACK INTO THE PATIENT'S ILIAC, POSSIBLY BECAUSE OF STENOSIS. THE DEVICE WAS REMOVED AND A SECOND PROGLIDE DEVICE WAS USED; HOWEVER, HEMOSTASIS WAS NOT ACHIEVED. HEMOSTASIS WAS ACHIEVED USING MANUAL COMPRESSION FOR APPROXIMATELY 15 MINUTES. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. 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 Required Intervention DEVICE #1: PROGLIDE (PART #12673-03, LOT #UNK)