BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 1932334 · Received December 17, 2010

    Report

    Report Number
    2953144-2010-03278
    Event Type
    Injury
    Date Received
    December 17, 2010
    Date of Event
    November 18, 2010
    Report Date
    November 24, 2010
    Manufacturer
    AV-REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. (CONCOMITANT MEDICAL PRODUCTS): PROCEDURAL SHEATH 22F; PROSTAR XL (PART #12322-02; LOT #900446H) THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. (B)(4) - INCORRECT ANATOMY (RIGHT FEMORAL VEIN) DEVICE #2 PROSTAR XL, PART# 12322-02, LOT# 900446H AND DEVICE #3 PROSTAR XL, PART# 12322-02, LOT# 900446H, ARE BEING REPORTED UNDER SEPARATE MEDWATCH REPORT NUMBERS.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED DEVICE FOUND IT WAS PARTIALLY DEPLOYED. THE LOCKING NOTCH OF THE HANDLE WAS FOUND TO HAVE BEEN BROKEN OFF, WHICH IS CONSISTENT WHEN THE HANDLE IS FORCEFULLY LOCKED DURING THE NEEDLE BACK-DOWN PROCEDURE. THE SUTURES WERE LOOSE INDICATING THEY WERE BACKED DOWN AFTER THE ATTEMPTED DEPLOYMENT. NEEDLE STRIKE MARKS WERE FOUND ON THE FACE OF THE BARREL THAT INDICATES THE NEEDLES WERE DEFLECTED DURING DEPLOYMENT CAUSING THEM TO MISS THE NEEDLE SLOTS AND STRIKE THE BARREL STOPPING DEPLOYMENT. POSSIBLE CAUSES FOR THE NEEDLES FAILING TO DEPLOY ARE DEPLOYING THE DEVICE AT AN ANGLE GREATER THAN 45 DEGREES AND/OR DEPLOYMENT IN PATIENTS WITH CHALLENGING ANATOMICAL CONDITIONS SUCH AS A CALCIFIED VESSEL, SCARRED ACCESS SITES, LACK OF DEVICE STABILITY, AND TORTUOUS DEPLOYMENT PATHS. THERE WAS NO OTHER DAMAGE DETECTED. DURING TESTING, THE NEEDLES WERE FULLY DEPLOYED AND HARVESTED WITHOUT DIFFICULTY. BASED ON THE INVESTIGATION, THE PROBABLE ROOT CAUSE FOR THE NEEDLES FAILING TO DEPLOY IS RELATED TO THE OPERATIONAL CONTEXT IN WHICH THE DEVICE WAS USED. NO MANUFACTURING OR QUALITY ISSUE WAS DETECTED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN IN-TRAINING IN THE USE OF THE PROSTAR XL DEVICE ATTEMPTED PRE-CLOSURE PLACEMENT OF THE SUTURES IN THE RIGHT FEMORAL VEIN PRIOR TO AN INTERVENTIONAL PROCEDURE. REPORTEDLY, THE NEEDLES WOULD NOT DEPLOY. THE DEVICE WAS REMOVED AND A SECOND PROSTAR XL DEVICE WAS ATTEMPTED BUT WITH THE SAME RESULTS, THE NEEDLES WOULD NOT DEPLOY. THE DEVICE WAS REMOVED AND A THIRD PROSTAR XL DEVICE WAS ATTEMPTED, BUT AFTER DEPLOYING THE NEEDLES WITH SOME DIFFICULTY, AT THE END OF THE CASE, THE SUTURES DID NOT ACHIEVE HEMOSTASIS AT THE SITE. MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. SIX HOURS AFTER THE PROCEDURE, THE ACCESS SITE HAD MILD OOZING; TREATMENT WAS UNSPECIFIED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. 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-REDWOOD CITY 900446H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention