BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 2113651 · Received June 3, 2011

    Report

    Report Number
    2024168-2011-03873
    Event Type
    Injury
    Date Received
    June 3, 2011
    Date of Event
    May 9, 2011
    Report Date
    May 9, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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 PATIENT WAS DESCRIBED AS (B)(6). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE FOUND IT WAS PARTIALLY DEPLOYED AND THE INTER-LOCK AND THE HANDLE IN THE LOCKED POSITIONS. THE SUTURE WAS LOOSE PROXIMAL OF THE DIMPLE CRIMP RING AND THE NEEDLES WERE IN THE SHEATH. THESES FINDINGS ARE CONSISTENT WITH AND CONFIRM THE REPORTED BACK DOWN PREFORMED DURING THE PROCEDURE. THE FACE OF THE BARREL WAS EXAMINED AND A NEEDLE STRIKE WITNESS MARK WAS DETECTED. THE WITNESS MARK OF THE NEEDLE STRIKE ON THE BARREL FACE INDICATES THE NEEDLES WERE DEFLECTED DURING DEPLOYMENT CAUSING THEM TO MISS THE NEEDLE SLOTS STRIKING THE BARREL STOPPING DEPLOYMENT. THE COILED SUTURE LUMENS HAD BEEN REMOVED AND NOT RETURNED WITH THE DEVICE. NEEDLE DEFLECTION CAN BE INFLUENCED BY NUMEROUS FACTORS THAT INCLUDE, BUT ARE NOT LIMITED TO: DEPLOYING DEVICE AT AN ANGLE GREATER THAN 45 DEGREES AND/OR DEPLOYMENT IN PATIENTS WITH CHALLENGING ANATOMICAL CONDITIONS SUCH AS A CALCIFIED OR SCARRED ACCESS SITE, LACK OF DEVICE STABILITY; TORTUOUS PATHS CAN ALSO AFFECT NEEDLE DEPLOYMENT DURING USE. IT WAS REPORTED THAT THE ANGLE OF THE STAR WAS CHANGED SLIGHTLY BUT NOT 45 DEGREES. THE REPORT OF DEVICE DEPLOYMENT BEING ATTEMPTED TWO ADDITIONAL TIMES AFTER THE INITIAL FAILED ATTEMPT, AND BACKING DOWN OF THE NEEDLES, IS NOT CONSISTENT WITH THE DEVICE INSTRUCTIONS FOR USE. UNDER TECHNIQUE FOR NEEDLE BACK-DOWN THE IFU STATES DO NOT ATTEMPT TO RE-DEPLOY THE PROSTAR XL DEVICE AFTER THE NEEDLES HAVE BEEN BACKED-DOWN. IT WAS ALSO REPORTED THAT ANOTHER PROSTAR XL DEVICE WAS USED TO ACHIEVE HEMOSTASIS WITHOUT DIFFICULTY. THERE WAS NO MANUFACTURING OR QUALITY INSPECTION DEFICIENCY DETECTED. BASED ON THE INVESTIGATIONAL FINDINGS, REPORTED INFORMATION AND THE INSPECTION CRITERIA, THE MOST PROBABLE CAUSE FOR THE FAILURE TO DEPLOY THE NEEDLES IS RELATED TO THE OPERATIONAL CONTEXT DURING USE AND USER TECHNIQUE. A REVIEW OF THE FINISHED DEVICE HISTORY RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. THERE DOES NOT APPEAR TO BE ANY INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN, TRAINED IN THE USE OF THE PROSTAR XL DEVICE, ATTEMPTED ARTERIOTOMY CLOSURE OF A MODERATELY TORTUOUS, MILDLY CALCIFIED COMMON FEMORAL ARTERY, AFTER AN ENDOVASCULAR AORTIC REPAIR (EVAR) PROCEDURE. REPORTEDLY, A PROPER NICK AND SPREAD WAS DONE AND THE PUNCTURE WAS AT A CLEAN SPOT. WHEN THE NEEDLES WERE RETRACTED THROUGH THE BARREL, ONLY ONE NEEDLE CAME ACTUALLY THROUGH THE BARREL. NEEDLE BACK-DOWN WAS PERFORMED, THE ANGLE OF THE STAR WAS CHANGED SLIGHTLY, BUT NOT 45 DEGREES. THE DEVICE WAS ATTEMPTED TO BE DEPLOYED TWO ADDITIONAL TIMES, HOWEVER ONLY 3 NEEDLES (NOT 4) CAME THROUGH THE BARREL. THE NEEDLES WERE BACKED DOWN, DEPLOYMENT TERMINATED AND THE DEVICE REMOVED FROM THE PATIENT. A NEW PROSTAR XL WAS USED WITH NO ISSUES AND HEMOSTASIS WAS ACHIEVED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECT. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSTAR XL SUTURE-MEDIATED CLOSURE SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 020076H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATHS: 10FR, 18 FR. HEPARIN.