BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE A-T SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1904794 · Received November 22, 2010

    Report

    Report Number
    2953144-2010-02887
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    October 21, 2010
    Report Date
    October 26, 2010
    Manufacturer
    AV-REDWOOD CITY
    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):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.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE PLUNGER AND NEEDLES, THE COMPLETE SUTURE, POSTERIOR NEEDLE TIP, ANTERIOR AND POSTERIOR CUFFS AND LINK MATERIAL WERE NOT RETURNED, WHICH LIMITED THE INVESTIGATION. EVALUATION OF THE RETURNED DEVICE COMPONENTS FOUND NO DETECTED DAMAGE TO THE DEVICE HANDLE, GUIDE TUBE, GUIDE, FOOT OR SHEATH. BLOW THROUGH MARKS WERE PRESENT ON THE POSTERIOR FOOT INDICATING THE POSTERIOR CUFF HAD BEEN EJECTED FROM THE POSTERIOR FOOT. INSPECTION OF THE FOOT ASSEMBLY DID NOT DETECT ANY DAMAGE TO INDICATE A POSSIBLE CUFF MISS OR NEEDLE STRIKE. DURING TESTED, A PROXY PLUNGER AND NEEDLE ASSEMBLY WERE INSERTED TO TEST NEEDLE TRAJECTORY AND THE RESULTS WERE SUCCESSFUL. A POSSIBLE CAUSE FOR THE REPORTED CUFF MISS MAY HAVE BEEN 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. HOWEVER, NONE OF THE POSSIBLE CAUSES FOR THE CUFF MISS EVENT COULD BE CONFIRMED. BASED ON THE INVESTIGATION FINDINGS, THE DEVICE PERFORMED ACCORDING TO SPECIFICATION AND THE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. NO MANUFACTURING OR QUALITY ISSUES WERE DETECTED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY INFORMATION RELEVANT TO THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PERCLOSE AT DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, A CUFF MISS OCCURRED AND "THE DEVICE WOULD NOT TAKE". A SECOND PERCLOSE DEVICE WAS USED SUCCESSFULLY TO ACHIEVE HEMOSTASIS. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A TRIAL THAT ON (B)(6) 2005, THE PATIENT UNDERWENT STENTING IN THE LEFT PROXIMAL CIRCUMFLEX ARTERY WITH ONE 3.0 X 18 XIENCE V STENT. ON (B)(6) 2010, THE PATIENT EXPERIENCED ANGINA AND UNDERWENT A DIAGNOSTIC CORONARY ANGIOGRAM THAT RESULTED IN A PERCUTANEOUS CORONARY REVASCULARIZATION IN THE LEFT PROXIMAL CIRCUMFLEX ARTERY WITH ADDITIONAL BALLOON ANGIOPLASTY AND STENTING USING ANOTHER XIENCE STENT. THE PATIENT'S CONDITION RESOLVED ON (B)(6) 2010. THERE WAS NO ADVERSE PATIENT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE A-T SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-REDWOOD CITY 930166H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention