BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1920090 · Received December 10, 2010

    Report

    Report Number
    2953144-2010-03182
    Event Type
    Injury
    Date Received
    December 10, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 17, 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

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE FOUND THAT THE DEVICE WAS IN THE PRE-PLUNGER DEPLOYMENT STATE WITH BLOOD PRESENT IN THE DEVICE. BOTH CUFFS WERE IN THE FOOT POCKETS WITH THEIR TABS INTACT. THE SHEATH WAS KINKED DISTAL OF THE SUTURE BEARING AND ALSO 2 CM PROXIMAL OF THE DISTAL TIP. DURING TESTING THE DEVICE WAS LOADED OVER A 0.035 GUIDE WIRE AFTER COAGULATED BLOOD WAS CLEANED FROM THE DEVICE INDICATING THAT THE GUIDE WIRE LOADING WAS NOT A CONTRIBUTING FACTOR IN THE EVENT. BASED ON THE INVESTIGATION FINDINGS THE REPORTED DIFFICULT INSERTION EXPERIENCE IS CONFIRMED. THE DAMAGE DETECTED INDICATES THE DEVICE WAS INSERTED AGAINST EXCESSIVE RESISTANCE CAUSING THE GUIDE TO BREAK. BASED ON THE FINDINGS OF THIS INVESTIGATION THE MOST PROBABLE ROOT CAUSE FOR THE DAMAGED SHEATH AND SUBSEQUENT FAILURE TO ACHIEVE HEMOSTASIS IS RELATED TO THE OPERATIONAL CONTEXT DURING USE OF THE DEVICE. NO MANUFACTURING OR QUALITY INSPECTION ISSUE WAS DETECTED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TECHNICIAN TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, DURING DEVICE INSERTION, THE SHEATH PORTION OF THE DEVICE "KINKED UP ON ITSELF". THE DEVICE WAS REMOVED AND THE SITE WAS REWIRED. A NON-ABBOTT DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT 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 920416H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention