BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE A-T SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2090356 · Received May 16, 2011

    Report

    Report Number
    2024168-2011-03498
    Event Type
    Injury
    Date Received
    May 16, 2011
    Date of Event
    April 21, 2011
    Report Date
    April 22, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. IMPROPER OR INCORRECT PROCEDURE OR METHOD, OPERATOR NOT TRAINED IN THE USE OF THE PROGLIDE DEVICE. THE FIRST AND THIRD PROGLIDE DEVICES ARE BEING FILED UNDER SEPARATE MEDWATCH MFR NUMBERS. THE RETURN OF THE PROGLIDE DEVICE MAY HAVE AIDED THE INVESTIGATION IN DETERMINING A CAUSE FOR THE REPORTED EXPERIENCED. TO ENSURE THIS TYPE OF EXPERIENCE IS NOT A RESULT OF A POTENTIAL PRODUCT RELATED DEFICIENCY, A SAMPLING OF FINISHED DEVICES IS ALSO TESTED TO VERIFY THE FUNCTIONALITY OF THE DEVICE. THE LOT HISTORY RECORD FOR THIS PRODUCT WAS NOT REVIEWED AND A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS NOT PERFORMED BECAUSE THE LOT NUMBER WAS NOT REPORTED AND THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED WITH THIS INCIDENT AND WITHOUT THE PRODUCT TO EXAMINE, A DEFINITIVE CAUSE FOR THE REPORTED EXPERIENCE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION RECEIVED. THE FIRST AND THIRD PERCLOSE AT DEVICES ARE BEING FILED UNDER SEPARATE MEDWATCH MFR NUMBERS. THE RETURN OF THE PERCLOSE AT DEVICE MAY HAVE AIDED THE INVESTIGATION IN DETERMINING A CAUSE FOR THE EXPERIENCED EVENT. THE REPORTED USE OF THE PERCLOSE AT DEVICE BY A PHYSICIAN NOT TRAINED IN THE USE OF THE DEVICE IS INCONSISTENT WITH THE INSTRUCTIONS FOR USE (IFU). DEVIATING FROM THE IFU MAY HAVE PLAYED A ROLE IN THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED COMPONENTS BODY OF THE DEVICE, HANDLE TO FOOT FUNCTION, GUIDE TUBE, NEEDLE GUIDE, BRIDGE, SUTURE BEARING, EXIT RAMP AND SHEATH WERE NORMAL WITH, THERE WAS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY THAT WOULD CONTRIBUTE TO THE REPORTED CUFF MISS. BOTH ENDS OF THE FOOT WERE ALSO EXAMINED AND THERE WERE NO NEEDLE STRIKE MARKS DETECTED. THERE WAS NO ABNORMAL OBSERVATION FOUND ON THE RETURNED DEVICE THAT COULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. SINCE, ONLY THE BODY OF THE DEVICE WAS RETURNED, THE SCOPE OF THE INVESTIGATION IS LIMITED AND THE REPORTED COMPLAINT CANNOT BE VERIFIED OR CONFIRMED. DURING THE INVESTIGATION, A PROXY PLUNGER WAS INSERTED BUT UNSUCCESSFULLY BECAUSE OF DRIED BLOOD INSIDE THE NEEDLE LUMENS. HOWEVER, THE NEEDLE TRAJECTORY OF EVERY DEVICE IS CHECKED DURING MANUFACTURING. BASED ON THE INVESTIGATION FINDINGS, THE MOST PROBABLE CAUSE FOR THE CUFF MISS IS NEEDLE DEFLECTION DURING PLUNGER DEPLOYMENT DUE TO PATIENT ANATOMY OR A FAILURE TO MAINTAIN A STABLE POSITION OF THE DEVICE DURING NEEDLE DEPLOYMENT. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY RELEVANT NONCONFORMING MATERIAL RECORDS FOR THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN USING THE PERCLOSE AT DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF AN UNSPECIFIED VESSEL AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE SUTURE DID NOT ENGAGE WITH THE VESSEL WALL. A SECOND AND THIRD DEVICE WERE USED WITH THE SAME RESULTS. THE SUTURE BROKE WHILE PULLING THE PLUNGER ASSEMBLY BACK AND REMOVING THE DEVICE ON ONE OF THE DEVICES. IT IS UNKNOWN HOW HEMOSTASIS WAS ACHIEVED. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL REPORT, IT WAS REPORTED THAT A PHYSICIAN USING THE PERCLOSE AT DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE LEFT COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE PHYSICIAN IS TRAINED IN THE USE THE PERCLOSE AT DEVICE.

    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-TEMECULA-CT 800426H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention HEPARIN