BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2183226 · Received July 28, 2011

    Report

    Report Number
    2024168-2011-05364
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    June 23, 2011
    Report Date
    July 8, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ANALYSIS OF THE RETURNED DEVICE NOTED THAT THE COMPLETE SUTURE WAS RETURNED INTACT AND UNBROKEN. HOWEVER, THE LINK WAS BROKEN PROXIMAL OF THE ANTERIOR CUFF WHICH WOULD RESULT IN THE FAILURE TO RETRIEVE THE SUTURE DURING PLUNGER REMOVAL. A LINK BREAK CAN ALSO HAVE THE SAME RESULT, APPEARANCE, AND PATIENT EFFECT AS THE REPORTED SUTURE BREAK. A LINK BREAK CAN BE INFLUENCED BY, BUT IS NOT LIMITED TO, MANUFACTURING, EXCESSIVE FORCE DURING PLUNGER REMOVAL, JERKY MOTION OR A SIDE WALL STICK, DEPLOYMENT IN A CHALLENGING ANATOMY. GENTLY REMOVING THE PLUNGER DURING THE FIRST 2 CM CAN REDUCE THE LINK BREAKAGE. BASED ON THE INVESTIGATION, THE LINK BREAK DETECTED AT THE ANTERIOR CUFF, RESULTING IN THE FAILURE TO HARVEST THE SUTURE DURING USE APPEARS TO BE RELATED TO THE OPERATIONAL INFLUENCES DURING USE AND NOT A PRODUCT QUALITY DEFICIENCY. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT. A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE DOES NOT APPEAR TO BE ANY INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. TO ASSURE THAT ALL PRODUCTS PERFORM ACCORDING TO SPECIFICATIONS THEY ARE SUBJECT INSPECTION DURING MANUFACTURING AND A QUALITY CONTROL AUDIT INSPECTION IS PERFORMED TO VERIFY PRODUCT QUALITY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE HAS BEEN RECEIVED. INVESTIGATION IS NOT COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PERCLOSE PROGLIDE DEVICE AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, THE SUTURE BROKE WHEN THE PLUNGER WAS REMOVED. ANOTHER PROGLIDE WAS USED TO ACHEIVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. REPORTEDLY, THE PHYSICIAN IS TRAINED IN THE USE OF THE DEVICE. 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 040416H

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention SHEATH: 6F