BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2110759 · Received June 1, 2011

    Report

    Report Number
    2024168-2011-03829
    Event Type
    Injury
    Date Received
    June 1, 2011
    Date of Event
    May 4, 2011
    Report Date
    May 11, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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. THE RETURN OF THE DEVICE MAY HAVE AIDED THE INVESTIGATION IN DETERMINING A CAUSE FOR THE EXPERIENCED EVENT. TO ENSURE THIS TYPE OF EXPERIENCE IS NOT A RESULT OF A POTENTIAL PRODUCT RELATED DEFICIENCY, A SAMPLING OF FINISHED DEVICES IS ALSO TESTED TO VERIFY THE FUNCTIONALITY OF THE DEVICE. A SUTURE MISLOCATION CAN OCCUR DUE TO A NUMBER OF FACTORS INCLUDING, BUT NOT LIMITED TO THE ROTATION OF DEVICE DURING PLUNGER/NEEDLE DEPLOYMENT AND FAILURE TO MAINTAIN ADEQUATE FOOT POSITION AGAINST THE ARTERIAL WALL. THIS MAY HAVE BEEN CONTRIBUTING FACTOR TO THIS EVENT, BUT CANNOT BE CONFIRMED. BASED ON THE INFORMATION RECEIVED WITH THIS COMPLAINT AND WITHOUT THE PRODUCT TO EXAMINE, A DEFINITIVE CAUSE FOR THE REPORTED EXPERIENCE CANNOT BE DETERMINED. THE OTHER 2 PROGLIDE DEVICES ARE BEING REPORTED UNDER SEPARATE MEDWATCH REPORT NUMBERS. 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 ATTEMPTED ARTERIOTOMY CLOSURE USING A PRE-CLOSE TECHNIQUE IN THE MODERATELY CALCIFIED AND MODERATELY TORTUOUS RIGHT COMMON FEMORAL ARTERY USING TWO PROGLIDE DEVICES PRIOR TO AN INTERVENTIONAL PROCEDURE (ABDOMINAL AORTIC ANEURYSM REPAIR). REPORTEDLY, THE PHYSICIAN UP SIZED THE SHEATH FROM AN 7FR TO AN 18FR SHEATH AND THE INTERVENTIONAL PROCEDURE WAS COMPLETED WITHOUT INCIDENT. DURING THE ARTERIOTOMY CLOSURE THE KNOTS WERE ADVANCED; HOWEVER, HEMOSTASIS WAS NOT ACHIEVED. A THIRD PROGLIDE DEVICE WAS USED AND STILL HEMOSTASIS WAS NOT ACHIEVED. THE PATIENT WAS TAKEN TO SURGERY WHERE THE VASCULAR SURGEON PERFORMED A CUT-DOWN PROCEDURE AND HEMOSTASIS WAS SURGICALLY ACHIEVED WITH SUTURES. DURING THE CUT-DOWN PROCEDURE IT WAS FOUND THAT THE PROGLIDE SUTURES HAD BEEN DEPLOYED IN SCAR TISSUE ABOVE THE ARTERY. 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-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 7FR, 18FRHEPARIN