BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1960091 · Received January 13, 2011

    Report

    Report Number
    2024168-2011-00273
    Event Type
    Injury
    Date Received
    January 13, 2011
    Date of Event
    December 20, 2010
    Report Date
    December 21, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE FOUND THAT IT WAS PARTIALLY DEPLOYED. THE PLUNGER WITH ANTERIOR NEEDLE TIP WAS NOT RETURNED. THE COMPLETE SUTURE WITH POSTERIOR NEEDLE TIP HAD BEEN PULLED OUT OF THE DEVICE. THE SUTURE WAS RETURNED UNBROKEN. BASED ON THIS FINDING THE REPORTED SUTURE BREAK IS NOT CONFIRMED. THE POSTERIOR CUFF WITH LINK WAS STILL IN THE FOOT POCKET AND ITS CUFF TABS WERE UNDISTURBED. THE ANTERIOR CUFF, HOWEVER, HAD BEEN PULLED OUT OF THE FOOT POCKET, WITH ITS TABS BENT INDICATING A NEEDLE TO CUFF DETACHMENT. BASED ON THE FINDINGS OF THE INVESTIGATION, A POSTERIOR CUFF MISS OCCURRED AS EVIDENCED BY THE POSTERIOR CUFF REMAINING IN THE FOOT POCKET. BECAUSE THE NEEDLE DID NOT ENGAGE THE POSTERIOR CUFF, THE CUFF WAS NOT EJECTED FROM THE FOOT. WHEN THE PLUNGER WAS REMOVED FROM THE DEVICE, THE LINK WAS HELD ON ONE END BY THE POSTERIOR CUFF IN THE FOOT POCKET WHILE BEING PULLED ON THE OTHER END BY THE WITHDRAWAL OF THE PLUNGER. THIS RESULTED IN THE ANTERIOR CUFF DETACHING FROM THE NEEDLE. A PROXY PLUNGER WAS INSERTED INTO THE DEVICE AND THE NEEDLE TRAJECTORY WAS ACCEPTABLE. THE POSTERIOR FOOT WAS EXAMINED AND NO NEEDLE STRIKE MARKS WERE DETECTED INDICATING THE POSTERIOR NEEDLE WAS DEFLECTED OUTSIDE OF THE FOOT POCKET DURING DEPLOYMENT. BASED ON THE ANALYSIS OF THE RETURNED DEVICE THE MOST PROBABLE CAUSE FOR THE POSTERIOR CUFF MISS AND SUBSEQUENT FAILURE TO ACHIEVE HARVEST THE SUTURE IS DUE TO NEEDLE DEFLECTION DURING PLUNGER DEPLOYMENT POSSIBLY CAUSED BY INTERACTION WITH ANATOMY OR A FAILURE TO MAINTAIN A STABLE POSITION OF THE DEVICE WITH RESPECT TO THE TISSUE TRACT DURING NEEDLE DEPLOYMENT. NO MANUFACTURING OR QUALITY INSPECTION ISSUE WAS DETECTED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, A SUTURE BREAK OCCURRED AND A NON- ABBOTT DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. HOWEVER, WHEN THE DEVICE WAS RETRIEVED IT APPEARED THAT THE SUTURES DIDN'T BREAK. THOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT 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 920046H

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention