BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2032848 · Received March 29, 2011

    Report

    Report Number
    2024168-2011-02122
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 4, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED DEPLOYED, MISSING ITS SUTURE, POSTERIOR NEEDLE TIP, ANTERIOR AND POSTERIOR CUFFS AND LINK. ANALYSIS OF THE DEVICE FOUND THE RETURNED BODY OF THE DEVICE, LEVER, FOOT, GUIDE, SHEATH AND PLUNGER/NEEDLES ASSEMBLY WITH NO DAMAGE DETECTED THAT WOULD CONTRIBUTE TO THE REPORTED FAILURE TO DEPLOY. BOTH ENDS OF THE FOOT WERE EXAMINED AND THERE WAS NO EVIDENCE OF NEEDLE STRIKE MARKS DETECTED AND BLOW-THROUGH MARKS WERE PRESENT ON THE POSTERIOR FOOT INDICATING POSTERIOR CUFF EJECTION FROM THE FOOT. AN ATTEMPT TO REINSERT THE PLUNGER NEEDLE ASSEMBLY INTO THE DEVICE TO TEST NEEDLE TRAJECTORY, NEEDLE DEPTH AND PUSH MANDREL TRAVEL WAS SUCCESSFUL WITH ALL PARAMETERS SUCCESSFUL. THE INVESTIGATION CONCLUDED THAT AN ANTERIOR CUFF MISS OCCURRED. 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. THE PATIENT WAS REPORTED TO HAVE ARTERIAL CALCIUM WHICH MAY HAVE CONTRIBUTED TO THE DETECTED FAILURE MODE; HOWEVER, IT COULD NOT BE CONFIRMED. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT FIND ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. A CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED AND THERE DOES NOT APPEAR TO BE ANY INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE PROGLIDE DEVICE IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF A CALCIFIED COMMON FEMORAL ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE PROGLIDE DEVICE FAILED TO DEPLOY. A SECOND PROGLIDE DEVICE WAS USED WITH THE SAME RESULTS. IT IS UNKNOWN HOW HEMOSTASIS WAS ACHIEVED. THERE WERE NO REPORTED ADVERSE PATIENT SEQUALE. 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 010166H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention