BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2131166 · Received June 16, 2011

    Report

    Report Number
    2024168-2011-04243
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    May 7, 2011
    Report Date
    May 25, 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). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. 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 FOUND THAT THE ANTERIOR CUFF WAS ATTACHED TO THE NEEDLE TIP WITH THE LINK AND POSTERIOR CUFF. THE POSTERIOR CUFF TABS WERE INTACT AND UNDAMAGED. THE COMPLETE SUTURE WITH THE POSTERIOR NEEDLE TIP WAS PARTIALLY LOADED IN THE DEVICE AND THE KNOT HAD NOT BEEN FORMED. THE POSTERIOR NEEDLE TIP WAS EXAMINED AND THERE WERE NO WITNESS MARKS OR DAMAGE DETECTED TO INDICATE CUFF CAPTURE, NEEDLE DETACHMENT OR STRIKING THE FOOT HAD OCCURRED. BOTH ENDS OF THE FOOT WERE EXAMINED AND THERE WERE NO NEEDLE STRIKE MARKS DETECTED, THIS FINDING INDICATES THE NEEDLE WAS DEFLECTED AWAY FROM THE FOOT POCKET. THESE FINDINGS ARE CONSISTENT WITH AND CONFIRM THE REPORTED NEEDLE TO CUFF MISS. DURING TESTING, THE PLUNGER WAS INSERTED TO TEST THE NEEDLE TRAJECTORY, DEPTH AND MANDREL TRAVEL AND THE RESULTS WERE ACCEPTABLE. THE NEEDLE TRAJECTORY OF EACH DEVICE IS INSPECTED DURING MANUFACTURING. 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. BASED ON THE INVESTIGATIONAL FINDING, THE CUFF EXPERIENCED DURING THE PROCEDURE APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT DURING USE OF THE DEVICE. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. THERE WAS NO MANUFACTURING OR QUALITY INSPECTION DEFICIENCY DETECTED.

    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, A CUFF MISS OCCURRED. A SECOND PROGLIDE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. 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 950386H

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention