BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1974280 · Received January 31, 2011

    Report

    Report Number
    2024168-2011-00559
    Event Type
    Injury
    Date Received
    January 31, 2011
    Date of Event
    January 7, 2011
    Report Date
    January 7, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. ADDITIONALLY, FOUR UNUSED STERILE REPRESENTATIVE SAMPLE DEVICES WITH THE SAME PART AND LOT NUMBER RELATED TO THIS PRODUCT EXPERIENCE WERE RETURNED FOR EVALUATION. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE REVEALED THAT ONLY THE BODY OF THE DEVICE WAS RETURNED, WITH BLOOD PRESENT. APPROXIMATELY SEVEN INCHES OF THE WHITE NON-RAIL SUTURE WAS RECEIVED. EXAMINATION UNDER MAGNIFICATION REVEALED NO STRETCHING OR TEARING OF THE SUTURE. THE DAMAGED END OF THE SUTURE HAD ABRASIONS AND WAS EVENLY BROKEN INDICATING THE SUTURE ENCOUNTERED RESISTANCE AGAINST A STRAIGHT SURFACE, WHICH IS CONSISTENT WITH DAMAGE CAUSED BY INCORRECT POSITIONING OF THE GATED SUTURE TRIMMER. THE PROGLIDE DEVICE INSTRUCTIONS FOR USE STATES UNDER SMC DEVICE PLACEMENT, THE RAIL SUTURE LIMB IS BLUE AND IS THE SUTURE LIMB THAT WILL BE USED TO ADVANCE THE KNOT. THE NON-RAIL SUTURE LIMB IS WHITE. IF THE WHITE NON-RAIL SUTURE LIMB IS USED TO ADVANCE THE KNOT TO THE ARTERIOTOMY, IT CAN TIGHTEN PREMATURELY ABOVE THE ARTERIOTOMY RESULTING IN BREAKAGE OR REMOVAL OF THE SUTURE FROM THE VESSEL. IN ADDITION, OTHER POSSIBLE CAUSES FOR A SUTURE BREAK INCLUDE: THE SUTURE BEING NICKED DURING ROTATION OF THE SUTURE TRIMMER, THE SUTURE TRIMMER THUMB KNOB BEING RELEASED WITH THE GATE CLOSING ON THE SUTURE, AND ADVANCEMENT OF THE SUTURE WITH A QUICK JERKY MOTION. A SUTURE BREAK CAN BE PREVENTED BY USING SLOW, CONSTANT, INCREASING TENSION, AND BY KEEPING THE SUTURE LIMBS COAXIAL AT ALL TIMES. THE OPERATOR WAS REPORTED TO BE IN-TRAINING IN THE USE OF THE PROGLIDE DEVICE AND BASED UPON THE DETECTED DAMAGED, THIS MAY HAVE BEEN A CONTRIBUTING FACTOR. BASED ON THE INVESTIGATION FINDINGS, THE PROBABLE ROOT CAUSE FOR THE PRODUCT EXPERIENCE IS RELATED TO USER TECHNIQUE AND THE OPERATIONAL CONTEXT IN WHICH THE DEVICE WAS USED. NO MANUFACTURING OR QUALITY ISSUE WAS DETECTED. ADDITIONALLY, FOUR UNUSED REPRESENTATIVE SAMPLE PROGLIDE DEVICES WITH THE SAME PART NUMBER AND LOT NUMBER AS THE PRODUCT EXPERIENCE WERE RETURNED FOR EVALUATION. EACH OF THE FOUR PROGLIDE DEVICES WAS FUNCTIONAL TESTED RESULTING IN ACCEPTABLE RESULTS. EACH DEVICE FUNCTIONING ACCORDING TO SPECIFICATIONS NO MANUFACTURING OR ABNORMAL OBSERVATIONS WERE DETECTED. A ROOT CAUSE RELATED TO THE PRODUCT EXPERIENCE COULD NOT BE DETERMINED BASED ON THE INVESTIGATION FINDINGS FROM THE FOUR UNUSED REPRESENTATIVE SAMPLES. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN IN-TRAINING IN THE USE OF THE PERCLOSE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, AS TENSION WAS APPLIED TO THE BLUE RAIL SUTURE LIMB TO ADVANCE THE KNOT TO THE ARTERIOTOMY, THE SUTURE BROKE. MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. 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 940046H

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention