BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1884715 · Received October 25, 2010

    Report

    Report Number
    2953144-2010-02591
    Event Type
    Injury
    Date Received
    October 25, 2010
    Date of Event
    September 30, 2010
    Report Date
    September 30, 2010
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4): EVALUATION SUMMARY: THE DEVICE WAS RECEIVED IN THE DEPLOYED CONFIGURATION. THE NEEDLE PLUNGER REMAINED INSIDE THE HANDLE OF THE DEVICE WITH THE NEEDLES HAVING BEEN FULLY DEPLOYED. THE POSTERIOR FOOT WAS DETACHED, BUT REMAINED ATTACHED TO THE DEVICE BY THE LINK MATERIAL. THE POSTERIOR NEEDLE TIP HAD BEEN EJECTED FROM THE POSTERIOR NEEDLE SHANK, AS DESIGNED AND WAS ATTACHED TO APPROXIMATELY ONE INCH OF SUTURE. THE POSTERIOR NEEDLE TIP HAD BEEN BROKEN OFF AND WAS NOT RETURNED. THE ANTERIOR AND POSTERIOR CUFFS REMAINED LOADED WITHIN THEIR RESPECTIVE FOOT POCKETS WITH THE ANTERIOR NEEDLE ENGAGED WITH THE ANTERIOR CUFF. THE POSTERIOR CUFF REMAINED LOADED IN THE POSTERIOR FOOT POCKET WITH DAMAGE DETECTED CONSISTENT WITH NEEDLE STRIKE MARKS. THERE WAS NO DETECTED DAMAGE TO THE DEVICE HANDLE, GUIDE TUBE, GUIDE, OR SHEATH. THE RECEIVED CONDITION OF THE DEVICE IS CONSISTENT WITH A DEVICE THAT WAS REMOVED WITH THE FOOT DEPLOYED THAT LIKELY CAUSED OR CONTRIBUTED TO THE BROKEN POSTERIOR PORTION OF THE FOOT, AND IS AN OPERATOR ERROR IN DEPLOYMENT SEQUENCE. THE OBSERVED DAMAGE TO THE POSTERIOR PORTION OF THE FOOT AND THE POSTERIOR CUFF NOT HAVING BEEN EJECTED FROM THE POSTERIOR FOOT POCKET, INDICATE THAT THE POSTERIOR NEEDLE STRUCK THE POSTERIOR PORTION OF THE FOOT INSTEAD OF ENGAGING WITH THE POSTERIOR CUFF, WHICH LIKELY CAUSED THE DEVICE TO JUMP BACKWARD AND MAY HAVE ALSO HAVE CONTRIBUTED TO THE BROKEN POSTERIOR PORTION OF THE FOOT. THE PROBABLE ROOT CAUSES FOR THE POSTERIOR NEEDLE-TO-CUFF MISS ARE NEEDLE DEFLECTION DURING NEEDLE PLUNGER DEPLOYMENT DUE TO INTERACTION WITH HUMAN TISSUE, AGGRESSIVE AND FAST DEPLOYMENT OF THE NEEDLE PLUNGER, OR A FAILURE TO MAINTAIN A STABLE POSITION OF THE DEVICE WITH RESPECT TO THE TISSUE TRACT DURING NEEDLE DEPLOYMENT. THE DETACHED POSTERIOR NEEDLE TIP IS LIKELY A RESULT OF THE POSTERIOR NEEDLE STRIKING THE FOOT INSTEAD OF ENGAGING WITH THE POSTERIOR CUFF AS DESIGNED. THE INSTRUCTIONS FOR USE STATE UNDER DEVICE PLACEMENT, DISENGAGE THE NEEDLES BY PULLING THE NEEDLE PLUNGER ASSEMBLY BACK AND COMPLETELY REMOVE THE PLUNGER AND NEEDLES FROM THE BODY OF THE DEVICE. RELAX THE DEVICE AND THEN RETURN THE FOOT TO ITS ORIGINAL POSITION BY PUSHING THE LEVER ON TOP OF THE DEVICE, DOWN TO ITS ORIGINAL POSITION. BASED ON THE FINDINGS, A ROOT CAUSE FOR THE REPORTED PRODUCT EXPERIENCE COULD NOT BE DETERMINED. NO MANUFACTURING OR QUALITY ISSUES WERE DETECTED. A 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 COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, DURING NEEDLE PLUNGER DEPLOYMENT, THE DEVICE "JUMPED BACKWARD" AND NEEDLE DEPLOYMENT COULD NOT BE COMPLETED. DIFFICULTY WAS ENCOUNTERED REMOVING THE DEVICE, BUT AFTER SOME "MANIPULATION", IT WAS FREED FOR REMOVAL. WHEN THE DEVICE WAS REMOVED, IT WAS NOTICED THAT THE FOOT HAD SEPARATED DOWN THE MIDDLE. ANGIOGRAPHY WAS USED TO ENSURE NO PARTS REMAINED IN THE PATIENT ANATOMY. DURING AN ATTEMPT TO CONTROL THE BLEEDING, AN 8F SHEATH WAS INSERTED AT THE SITE BUT BLEEDING CONTINUED. THE 8F SHEATH WAS UPSIZED TO AN 18F SHEATH, PERCUTANEOUS ACCESS WAS OBTAINED CONTRALATERALLY, AND A NON-ABBOTT COVERED STENT WAS PLACED AT THE ACCESS SITE TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 920226H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention