BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2211899 · Received August 15, 2011

    Report

    Report Number
    2024168-2011-05733
    Event Type
    Injury
    Date Received
    August 15, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 21, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE DISCARDED AT THE SITE. IT WAS INITIALLY REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS. SUBSEQUENT INFORMATION REVEALED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. A CUFF MISS CAN BE INFLUENCED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO: MANUFACTURING, USER TECHNIQUE, OR ANATOMICAL CONDITIONS. THE NEEDLE TRAJECTORY OF EVERY DEVICE IS VERIFIED DURING MANUFACTURING AND A SAMPLING OF FINISHED DEVICES IS DESTRUCTIVELY TESTED TO VERIFY THE FUNCTIONALITY OF THE DEVICE. USER TECHNIQUE, SUCH AS, FAILURE TO POSITION AND MAINTAIN THE DEVICE AT A 45 DEGREE ANGLE THROUGHOUT DEPLOYMENT, ROTATING THE DEVICE AT ANY POINT DURING PLUNGER/NEEDLE DEPLOYMENT, AGGRESSIVELY DEPLOYING OR REMOVING THE PLUNGER AND / OR INADEQUATE POSITIONING OF THE FOOT AGAINST THE ARTERIAL WALL MAY CONTRIBUTE TO A CUFF MISS. INFORMATION CONCERNING USER TECHNIQUE WAS NOT PROVIDED. PATIENT ANATOMY (E.G. HEAVILY CALCIFIED ARTERIES, MORBIDLY OBESE PATIENTS, ETC.) MAY CONTRIBUTE TO A CUFF MISS. REPORTEDLY, A FEMORAL ANGIOGRAM REVEALED NO CALCIFICATION IN THE ARTERY OF THE PATIENT. NO OTHER RELEVANT PATIENT ANATOMICAL CONDITION WAS PROVIDED. A CONCLUSIVE CAUSE FOR THE REPORTED CUFF MISS COULD NOT BE DETERMINED. REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND NO MANUFACTURING OR QUALITY DEFICIENCY WAS DETECTED.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN ATTEMPTED ARTERIOTOMY CLOSURE OF A NON-CALCIFIED LEFT COMMON FEMORAL ARTERY (LCFA) AFTER A SUPERFICIAL FEMORAL ARTERY ANGIOPLASTY PROCEDURE USING A PROGLIDE DEVICE. REPORTEDLY, WHEN THE PLUNGER WAS RETRACTED FROM THE DEVICE BODY, A CUFF MISS OCCURRED, THE DEVICE WAS REMOVED AND ANOTHER PROGLIDE WAS USED SUCCESSFULLY TO ACHIEVE HEMOSTASIS. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECT. THE ACCESS SITE WAS DESCRIBED AS NOT CALCIFIED OR SCARRED. A 6 FR. SHEATH WAS USED DURING VESSEL CLOSURE. THE PHYSICIAN IS TRAINED IN THE USE OF THE PROGLIDE 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 050366H

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention SHEATH: 6 FR.