BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1914168 · Received December 3, 2010

    Report

    Report Number
    2953144-2010-03082
    Event Type
    Injury
    Date Received
    December 3, 2010
    Date of Event
    November 9, 2010
    Report Date
    November 9, 2010
    Manufacturer
    AV-REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: INVESTIGATION OF THE DEVICE FOUND IT WAS RETURNED WITHOUT THE ANTERIOR AND POSTERIOR CUFFS, POSTERIOR NEEDLE TIP, LINK AND SUTURE. BLOW THROUGH MARKS WERE PRESENT ON THE POSTERIOR FOOT, INDICATING THE POSTERIOR CUFF HAD BEEN PROPERLY EJECTED FROM THE POSTERIOR FOOT. THERE WAS NO DETECTED DAMAGE TO THE DEVICE HANDLE OR PLUNGER/NEEDLE ASSEMBLIES. FURTHER EXAMINATION INDICATED THAT AN ANTERIOR CUFF MISS OCCURRED CONFIRMING THE REPORTED EXPERIENCE. BECAUSE THE ANTERIOR CUFF DID NOT ENGAGE THE ANTERIOR NEEDLE DURING NEEDLE DEPLOYMENT, THE SUTURE COULD NOT BE RETRIEVED WHEN RETRACTING THE NEEDLE PLUNGER AS DESIGNED. THE DEVICE WAS TESTED FOR PROPER NEEDLE TRAJECTORY, PUSH MANDREL TRAVEL, AND NEEDLE DEPTH BY INSERTING THE RETURNED PLUNGER/NEEDLE ASSEMBLY INTO THE HANDLE ASSEMBLY. THE INSERTION WAS SUCCESSFUL WITH BOTH NEEDLES ENTERING THEIR RESPECTIVE FOOT POCKET AND THE TESTED PARAMETERS WERE MET, INDICATED PROPER NEEDLE DEPLOYMENT. POSSIBLE CAUSES FOR THE CUFF MISS ARE NEEDLE DEFLECTION DURING PLUNGER DEPLOYMENT DUE TO INTERACTION WITH HUMAN TISSUE, AGGRESSIVE AND FAST DEPLOYMENT OF THE PLUNGER, OR A FAILURE TO MAINTAIN A STABLE POSITION OF THE DEVICE WITH RESPECT TO THE TISSUE TRACT DURING NEEDLE DEPLOYMENT. THE PATIENT WAS REPORTED TO HAVE A HISTORY OF PERIPHERAL VASCULAR DECEASE AND IS OBESE, BOTH OF WHICH MAY HAVE PLAYED A ROLE IN THE PROCEDURE. THE NEEDLE TRAJECTORY OF EVERY DEVICE IS CHECK TWICE DURING MANUFACTURING. NO MANUFACTURING OR QUALITY ISSUES WERE DETECTED. BASED ON THE INVESTIGATION FINDINGS, THE ROOT CAUSE FOR THE REPORTED EVENT IS RELATED TO THE OPERATIONAL CONTEXT IN WHICH THE DEVICE WAS USED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS LEAD SUFFERED FROM TWIDDLER'S SYNDROME. AS A RESULT, THE RIGHT VENTRICULAR (RV) LEAD HAD BECOME DISLODGED. AN INVASIVE REVISION PROCEDURE WAS PERFORMED, AND THE RV LEAD WAS REMOVED. UPON REMOVAL, TISSUE WAS OBSERVED IN THE HELIX OF THE SCREW, THEREFORE, THE PHYSICIAN ELECTED TO REPLACE THE LEAD. NO FURTHER COMPLICATION WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TECHNICIAN TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, A CUFF MISS OCCURRED. ANOTHER PROGLIDE WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT SEQUELA. 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-REDWOOD CITY 930376H

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention