BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2143203 · Received June 28, 2011

    Report

    Report Number
    2024168-2011-04536
    Event Type
    Injury
    Date Received
    June 28, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 3, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE PROGLIDE DEVICE NOTED THAT THE SUTURE, POSTERIOR CUFF, AND POSTERIOR NEEDLE TIP WERE NOT RETURNED WITH THE DEVICE, WHICH LIMITED THE SCOPE OF THE INVESTIGATION. THE RETURNED CONDITION OF THE DEVICE SUGGESTS THAT NEEDLE PLUNGER DEPLOYMENT AND SUTURE RETRIEVAL WERE SUCCESSFUL. HOWEVER, INSTEAD OF CUTTING THE SUTURE FROM THE ANTERIOR NEEDLE DISTAL OF THE LINK AS INSTRUCTED IN THE INSTRUCTIONS FOR USE (IFU), IT WAS FOUND THAT THE LINK WAS CUT INSTEAD. THE IFU STATES UNDER THE DEVICE PLACEMENT SECTION TO DISENGAGE THE NEEDLES BY PULLING THE PLUNGER ASSEMBLY BACK AND COMPLETELY REMOVE THE PLUNGER AND NEEDLES FROM THE BODY OF THE DEVICE. ONE SUTURE LIMB WILL BE ATTACHED TO ONE END OF THE LINK. THE OTHER END OF THE LINK WILL BE ATTACHED TO THE ANTERIOR NEEDLE. THE POSTERIOR NEEDLE WILL BE FREE OF SUTURE. PULL BACK ON THE PLUNGER UNTIL THE SUTURE IS PULLED TAUT. CUT THE SUTURE FROM THE ANTERIOR NEEDLE DISTAL OF THE LINK. USE OF THE QUICKCUT SUTURE-TRIMMING MECHANISM LOCATED ON THE HANDLE. MANUFACTURING DEFICIENCIES, ANATOMICAL CONDITIONS, AND DEPLOYMENT TECHNIQUE CAN CONTRIBUTE TO A REPORTED KNOT LOCK; HOWEVER, THERE WERE NO REPORTED SUCH ISSUES. A REVIEW OF THE DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. A QUERY OF THE COMPLAINT DATABASE FOR THIS LOT REVEALED NO OTHER INCIDENTS WITH REPORTED KNOT LOCK DURING KNOT ADVANCEMENT. OVERALL, THERE DOES NOT APPEAR TO BE ANY INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. BASED ON THE EVALUATION FINDINGS, THE REPORTED PRODUCT EXPERIENCE COULD NOT BE CONFIRMED AND A DEFINITIVE CAUSE COULD NOT BE IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE SECOND PROGLIDE DEVICE IS BEING FILED UNDER A SEPARATE MANUFACTURER REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PERCLOSE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, WHILE REMOVING THE NEEDLE PLUNGER, THE BLUE (RAIL) SUTURE WAS PULLED; HOWEVER, THE KNOT DID NOT MOVE. THE DEVICE WAS REMOVED AND A SECOND PROGLIDE WAS ATTEMPTED; HOWEVER, WHEN THE BLUE (RAIL) SUTURE WAS PULLED, THE KNOT ALSO DID NOT MOVE AND IT FELT AS IF THE KNOT TIGHTENED WHILE THE BLUE SUTURE WAS BEING PULLED. THUS, THE WHITE SUTURE WAS PULLED AND THE KNOT DID ADVANCE TOWARDS THE VESSEL. ALTHOUGH SLIGHT OOZING WAS OBSERVED, HEMOSTASIS WAS ACHIEVED WITH MANUAL ARTERIAL COMPRESSION. IT WAS BELIEVED THAT THE BLUE SUTURES WERE ATTACHED TO THE PARTS WHERE THE WHITE SUTURES SHOULD HAVE BEEN ATTACHED. THE PHYSICIAN IS TRAINED IN THE USE OF THE PERCLOSE PROGLIDE. 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-TEMECULA-CT 920086H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention