BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE A-T SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2131623 · Received June 16, 2011

    Report

    Report Number
    2024168-2011-04261
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    May 25, 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
    NY, 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. INDICATION FOR USE (USED FOR CLOSURE OF A LARGE PUNCTURE HOLE). THE OTHER PERCLOSE AT DEVICES IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. WITHOUT THE PRODUCT TO EXAMINE, A CAUSE FOR THE INABILITY TO ADVANCE THE KNOT COULD NOT BE DETERMINED. HOWEVER, THE REPORTED USE OF THE DEVICE IN A LARGE HOLE IS NOT CONSISTENT WITH THE INSTRUCTIONS FOR USE (IFU) AND MAY HAVE PLAYED A ROLE IN THIS EVENT. THE IFU, UNDER INDICATIONS FOR USE, STATES THE PERCLOSE AT IS INDICATED FOR THE PERCUTANEOUS DELIVERY OF SUTURE FOR CLOSING THE COMMON FEMORAL ARTERY ACCESS SITE OF PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL CATHETERIZATION PROCEDURES USING 5F TO 8F SHEATHS. TO ASSURE THAT ALL PRODUCTS PERFORM ACCORDING TO SPECIFICATIONS THEY ARE SUBJECT TO INSPECTION DURING MANUFACTURING. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS PERFORMED TO VERIFY PRODUCT QUALITY. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY MANUFACTURING RELATED NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAS BEEN NO OTHER INCIDENT REPORTED FOR THIS LOT. THERE DOES NOT APPEAR TO BE ANY INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN, TRAINED IN THE USE OF THE PERCLOSE AT, ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, TWO DEVICES WERE DEPLOYED USING A PRECLOSE TECHNIQUE PRIOR TO THE INTERVENTIONAL PROCEDURE. AFTER THE PROCEDURE, THE TWO SUTURE KNOTS COULD NOT BE ADVANCED TO CLOSE THE LARGE SHEATH HOLE. THE SUTURES WERE REMOVED AND TWO ADDITIONAL PERCLOSE AT DEVICES WERE DEPLOYED WITH THE SAME RESULTS. HEMOSTASIS WAS ACHIEVED USING AN ADDITIONAL TWO PERCLOSE AT DEVICES. 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 A-T SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 020346H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention