BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 1923344 · Received December 13, 2010

    Report

    Report Number
    2953144-2010-03208
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    November 10, 2010
    Report Date
    November 18, 2010
    Manufacturer
    AV-REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSICIAN IS NOT TRAINED. (B)(4): OPERATOR NOT TRAINED. EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE FOUND THAT THE HANDLE WAS IN A BACKDOWN POSITION. THERE WAS A CLAMP MARK ON THE COILED SUTURE LUMEN. THE NEEDLES AND SUTURES WERE NOT RETURNED. THERE WAS NO NEEDLE STRIKE MARK ON THE BARREL FACE. BASED ON THE INVESTIGATION FINDINGS, THE CLAMP MARKS FOUND ON THE COILED SUTURE LUMEN AND THE COLLAPSED SUTURE TUBE AT THE HUB AREA IS AN INDICATION THAT A HEMOSTAT WAS APPLIED BEFORE THE NEEDLE DEPLOYMENT. CLAMPING OF THE SUTURE TUBE INTERFERED WITH SUTURE DEPLOYMENT AND NEEDLE TRAJECTORY CAUSING THE NEEDLE TO BEND AND STRIKE THE BARREL FACE. THERE WERE NO ABNORMAL OBSERVATIONS WITH THE CONDITION OF THE RETURNED DEVICE THAT COULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. THEREFORE, THE ROOT CAUSE FOR THESE FAILURE MODES IS DUE TO INCORRECT TECHNIQUE. THERE WERE NO MANUFACTURING OR QUALITY ISSUES DETECTED THAT COULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4).

    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.THE FIRST PROSTAR 12322-01/840066H, INDICATED IS BEING FILED UNDER A SEPARATE MFR#.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PROSTAR XL DEVICE ATTEMPTED ARTERIOTOMY CLOSURE, USING A PRECLOSE TECHNIQUE, OF THE LEFT FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, AFTER NEEDLE DEPLOYMENT,THERE WERE NO SUTURES ATTACHED TO THE NEEDLES. A HEMOSTAT WAS USED TO PULL THE NEEDLES OUT. THE SAME OCCURRED FOR A SECOND PROSTAR XL DEVICE USED. HEMOSTASIS WAS ACHIEVED USING A THIRD PROSTAR XL DEVICE. THE PHYSICIAN BELIEVED THE NEEDLES OR SUTURES WERE THICKER THAN NORMAL. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH ADDITIONAL INFORMATION INDICATES THE PHYSICIAN, NOT TRAINED IN USE OF THE PROSTAR XL, THINKS THE NEEDLES OR THE SUTURES WERE THICKER THAN NORMAL, BECAUSE THE THIRD PROSTAR XL USED IN THE SAME PATIENT WORKED NORMALLY AND CLOSURE WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSTAR XL SUTURE-MEDIATED CLOSURE SUTURE MEDIATED CLOSURE MGB AV-REDWOOD CITY 890216H

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention #1 PROSTAR 12322-01/(B)(4) F SHEATH