BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2020381 · Received March 16, 2011

    Report

    Report Number
    2024168-2011-01761
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    February 14, 2011
    Report Date
    February 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
    TX, 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. (B)(6). DATE OF EVENT WAS REPORTED AS DURING THE WEEK PRIOR TO THE DATE IT WAS REPORTED TO THE MANUFACTURER REPRESENTATIVE. THE DATE OF (B)(6) 2011 IS BEING USED AS THE BEST ESTIMATE DATE. THE DEVICE WAS RECEIVED. 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 CONFIRMED THE REPORTED EXPERIENCE OF NO SUTURE BEING PRESENT ON THE NEEDLES DURING PLUNGER REMOVAL, AS THE COMPLETE SUTURE WAS RETURNED WITH THE POSTERIOR NEEDLE TIP NOT ATTACHED TO THE CUFF. THE PLUNGER WITH ANTERIOR NEEDLE TIP, CUFFS AND LINK WERE NOT RETURNED WITH THE DEVICE. THIS TYPE OF ISSUE MAY OCCUR IF THE OPERATOR FAILS TO POSITION AND MAINTAIN THE DEVICE AT A 45 DEGREE ANGLE THROUGHOUT DEPLOYMENT, ROTATES THE DEVICE AT ANY POINT DURING PLUNGER/NEEDLE DEPLOYMENT, DEPLOYS THE DEVICE IN CHALLENGING ANATOMIES (E.G. HEAVY CALCIFIED ARTERIES, MORBIDLY OBESE PATIENTS, ETC.), AGGRESSIVELY DEPLOYS THE PLUNGER OR AGGRESSIVELY REMOVES THE PLUNGER OR FAILS TO MAINTAIN ADEQUATE FOOT POSITION AGAINST THE ARTERIAL WALL. DURING RETURN DEVICE TESTING A PROXY PLUNGER WAS INSERTED INTO THE DEVICE AND THE NEEDLE TRAJECTORY WAS ACCEPTABLE. BOTH ENDS OF THE FOOT WERE EXAMINED AND THERE WERE NO NEEDLE STRIKE MARKS DETECTED, THIS FINDING INDICATES THE NEEDLES MAY HAVE BEEN DEFLECTED OUTSIDE OF THE FOOT POCKET DURING USE. THE ANALYSIS OF THE RETURNED COMPONENTS FOUND NO INDICATION OF A PRODUCT QUALITY PROBLEM THAT WOULD CONTRIBUTE TO THE REPORTED EXPERIENCE. BASED ON THE ANALYSIS OF THE RETURNED COMPONENTS A ROOT CAUSE FOR THE REPORTED EXPERIENCE COULD NOT BE DETERMINED. THE NEEDLE TRAJECTORY OF EACH DEVICE IS INSPECTED TWICE DURING MANUFACTURING. A REVIEW OF THE FINISHED DEVICE HISTORY RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. THERE DOES NOT APPEAR TO BE ANY INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN, TRAINED IN THE USE OF THE PROGLIDE DEVICE, ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, DURING PLUNGER REMOVAL NO SUTURE WAS PRESENT ON THE NEEDLES. THE PROGLIDE DEVICE WAS REMOVED AND A NON-ABBOTT DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT EFFECT. 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 940226H

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention OTHER: ANGIOMAX