BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2040235 · Received April 5, 2011

    Report

    Report Number
    2024168-2011-02375
    Event Type
    Injury
    Date Received
    April 5, 2011
    Date of Event
    January 10, 2011
    Report Date
    March 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
    NC, 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 IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED COMPONENTS OF THE DEVICE FOUND, THE HANDLE TO FOOT FUNCTION, GUIDE TUBE, NEEDLE GUIDE, BRIDGE, SUTURE BEARING, EXIT RAMP AND SHEATH WERE NORMAL, WITH NO INDICATION OF A PRODUCT QUALITY DEFICIENCY THAT WOULD CONTRIBUTE TO THE REPORTED CUFF MISS. BOTH ENDS OF THE FOOT WERE ALSO EXAMINED AND THERE WERE NO NEEDLE STRIKE MARKS DETECTED. THERE WAS NO MANUFACTURING OR QUALITY INSPECTION DEFICIENCY DETECTED WITH THE RETURNED COMPONENTS THAT WOULD CONTRIBUTE TO THE REPORTED NEEDLE TO CUFF MISS EXPERIENCE. A CUFF-MISS CAN BE INFLUENCED BY MANY FACTORS, INCLUDING, BUT NOT LIMITED TO; MANUFACTURING, FAILURE TO POSITION AND MAINTAIN THE DEVICE AT A 45-DEGREE ANGLE THROUGHOUT DEPLOYMENT, ROTATING THE DEVICE AT ANY POINT DURING PLUNGER/NEEDLE DEPLOYMENT, DEPLOYMENT IN CHALLENGING ANATOMIES (E.G. HEAVY CALCIFIED ARTERIES, MORBIDLY OBESE PATIENTS, ETC.), AGGRESSIVELY DEPLOYING OR REMOVING THE PLUNGER AND / OR INADEQUATE POSITIONING OF THE FOOT AGAINST THE ARTERIAL WALL. TO ASSURE THAT ALL PRODUCTS PERFORM ACCORDING TO SPECIFICATIONS THEY ARE SUBJECT TO AN INSPECTION DURING MANUFACTURING. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS PERFORMED TO VERIFY PRODUCT QUALITY. BASED ON THE INVESTIGATION FINDINGS, THE REPORTED NEEDLE TO CUFF MISS COULD NOT BE CONFIRMED AND NO CAUSE COULD BE DETERMINED. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. THIS TYPE OF REPORTED ISSUE WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE ATTEMPTED PRE-CLOSE SUTURE PLACEMENT FOR ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL VALVULOPLASTY PROCEDURE. REPORTEDLY, A NEEDLE-TO-CUFF MISS OCCURRED. WHEN THE NEEDLE PLUNGER WAS PULLED FOR REMOVAL, NO SUTURE WAS ATTACHED TO THE NEEDLES. THE DEVICE WAS REMOVED OVER A GUIDE WIRE AND A SECOND PROGLIDE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELA. 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 940356H

    Patients

    Seq Age Sex Outcome Treatment
    1 97 YR Required Intervention