BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 2171792 · Received July 22, 2011

    Report

    Report Number
    2024168-2011-05078
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    June 29, 2011
    Report Date
    June 29, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ANALYSIS OF THE RETURNED DEVICE FOUND THE HANDLE WAS IN BACKDOWN POSITION AND THERE WAS PRESENCE OF SLACK ON THE SUTURES INDICATING THAT THE DEVICE WAS DEPLOYED. THERE WERE CLAMP MARKS FOUND ON THE SUTURE AND MARKER TUBES. THERE WAS A NEEDLE STRIKE MARK ON THE BARREL FACE AND ON THE GUIDE SHOULDER. DURING THE INVESTIGATION, THE HANDLE WAS UNABLE TO DEPLOY AS ONE OF THE NEEDLES WAS DISPLACED INSIDE THE SHEATH. THE EVIDENCE OF THE NEEDLE STRIKE MARK ON THE BARREL SUGGESTED THAT THE NEEDLE MIGHT HAVE BEEN DEFLECTED BY AN UNIDENTIFIED CAUSE. DEPLOYING THE DEVICE AT AN ANGLE GREATER THAN 45 DEGREES AND/OR PATIENT ANATOMICAL CONDITION CAN DEFLECT THE NEEDLES. IT WAS REPORTED THAT THERE WAS MODERATE TO HEAVY CALCIFICATION OF THE COMMON FEMORAL ARTERY AND THE PATIENT WAS DESCRIBED AS BEING OVER 200 LBS WITH A HISTORY OF PERIPHERAL VASCULAR DISEASE ALL OF WHICH MAY HAVE CONTRIBUTED TO THE EVENT. THE PROBABLE CAUSE FOR THE NEEDLE STRIKE MARK ON THE BARREL FACE AND FOR NEEDLE NOT PRESENTING AT THE HUB DURING NEEDLE DEPLOYMENT IS RELATED TO THE OPERATIONAL CONTEXT IN WHICH THE DEVICE WAS USED. THE CLAMP MARKS FOUND ON THE SUTURE TUBES COULD HAVE BEEN CAUSED WHEN THE OPERATOR CLAMPED THE MARKER TUBE TO STOP THE BLOOD FLOW. THE NEEDLE DEPLOYMENT OF EVERY DEVICE IS CHECK DURING THE MANUFACTURING PROCESS, TO ENSURE THAT THE NEEDLES/SUTURES ARE IN THE CORRECT ORIENTATION. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT. A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND 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 AN ARTERIOTOMY CLOSURE OF THE MODERATE TO HEAVILY CALCIFIED RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PROSTAR XL DEVICE AFTER AN AORTIC VALVULOPLASTY PROCEDURE. REPORTEDLY, DURING NEEDLE DEPLOYMENT, ONE NEEDLE DEFLECTED. PER THE INSTRUCTIONS FOR USE, A NEEDLE BACKDOWN TECHNIQUE WAS USED TO REMOVE THE DEVICE; HOWEVER, IT TOOK THREE TRIES BEFORE IT WAS SUCCESSFULLY REMOVED. A 10F SHEATH WAS INSERTED AND HEMOSTASIS WAS ACHIEVED WITH MANUAL ARTERIAL COMPRESSION. THERE WAS NO ADVERSE PATIENT SEQUELA. REPORTEDLY, THE PHYSICIAN IS TRAINED IN THE USE OF THE DEVICE. 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 950176H

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention OTHER: HEPARIN