BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2131467 · Received June 16, 2011

    Report

    Report Number
    2024168-2011-04254
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    April 29, 2011
    Report Date
    May 25, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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 DEVICE WAS NOT RETURNED FOR ANALYSIS. WITHOUT DEVICE EVALUATION, A CAUSE FOR THE UNUSUAL SOUND AND CUFF MISS COULD NOT BE DETERMINED. HOWEVER, A CUFF-MISS CAN BE INFLUENCED BY MANY FACTORS INCLUDING, BUT NOT LIMITED TO, MANUFACTURING, FAILURE TO POSITION AND MAINTAIN THE DEVICE AT A 45 DEGREE ANGLE THROUGHOUT DEPLOYMENT, ROTATING THE DEVICE AT ANY POINT DURING PLUNGER/NEEDLE DEPLOYMENT, DEPLOYMENT IN A CHALLENGING ANATOMY, AGGRESSIVELY DEPLOYING OR REMOVING THE PLUNGER AND/OR INADEQUATE POSITIONING OF THE FOOT AGAINST THE ARTERIAL WALL. WHETHER THESE CONDITIONS PLAYED A ROLE IN THE EXPERIENCED EVENT CANNOT BE VERIFIED. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY MANUFACTURING RELATED NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. BASED ON THE INFORMATION AVAILABLE, THE INSPECTION CRITERIA AND THE REVIEW OF THE LOT HISTORY RECORD, THERE DOES NOT APPEAR TO BE ANY INDICATIONS OF A PRODUCT QUALITY DEFICIENCY. TO ENSURE THIS TYPE OF EXPERIENCE IS NOT A RESULT OF A POTENTIAL PRODUCT RELATED DEFICIENCY, IN-PROCESS TESTING OF DEVICES ARE PERFORMED TO ASSURE THE TRAJECTORY OF NEEDLES IN ORDER TO PREVENT THIS MODE OF FAILURE. IN ADDITION, A SAMPLING OF FINISHED DEVICES IS TESTED TO VERIFY THE FUNCTIONALITY OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN, TRAINED IN THE USE OF THE PERCLOSE PROGLIDE, ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY OF THE ILLIAC ARTERY. REPORTEDLY, DURING DEPLOYMENT OF THE NEEDLES, AN UNUSUAL SOUND WAS HEARD WHEN THE NEEDLE TIP CLICKED IN THE FOOT. A CUFF MISS OCCURRED. ANOTHER PROGLIDE WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT SEQUELA. 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 020196H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GUIDE WIRE: TERUMO .035SHEATH: CORDIS 6F