BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2082432 · Received May 9, 2011

    Report

    Report Number
    2024168-2011-03336
    Event Type
    Injury
    Date Received
    May 9, 2011
    Date of Event
    March 23, 2011
    Report Date
    April 14, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED DEVICE FOUND THE PLUNGER, ANTERIOR NEEDLE, LINK, AND BOTH CUFFS WERE NOT RETURNED WITH THE DEVICE WHICH LIMITED THE SCOPE OF THE INVESTIGATION. INSPECTION OF THE RETURNED DEVICE REVEALED NO NEEDLE STRIKE MARK AT THE POSTERIOR FOOT. HOWEVER, THERE WAS CALCIUM OBSERVED AND THE POSTERIOR NEEDLE TIP HAD BEEN INDENTED. THIS IS INDICATIVE OF THE POSTERIOR NEEDLE BEING DEFLECTED AWAY FROM THE POSTERIOR FOOT AND INTERACTED WITH HUMAN TISSUE INSTEAD OF ENGAGED WITH THE POSTERIOR CUFF INSIDE THE POSTERIOR FOOT POCKET DURING NEEDLE DEPLOYMENT AS DESIGNED. DURING TESTING, A PROXY PLUNGER WAS INSERTED TO TEST THE NEEDLE TRAJECTORY AND PUSH MANDREL TRAVEL AND THE RESULTS MET THE MANUFACTURING CRITERIA. BASED ON THE INVESTIGATION FINDINGS, THE PROBABLE CAUSE FOR THE POSTERIOR CUFF MISS IS NEEDLE DEFLECTION DURING PLUNGER DEPLOYMENT DUE TO INTERACTION WITH HUMAN TISSUE OR A FAILURE TO MAINTAIN A STABLE POSITION OF THE DEVICE WITH RESPECT TO THE TISSUE TRACT. THIS IS CONSISTENT WITH CALCIUM OBSERVED AT THE POSTERIOR FOOT. A REVIEW OF THE PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. NO MANUFACTURING OR QUALITY DEFICIENCY WAS DETECTED. 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 DEVICE HAS BEEN RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN USING THE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN UNSPECIFIED 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 970026H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention