BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 2011075 · Received March 8, 2011

    Report

    Report Number
    2024168-2011-01528
    Event Type
    Injury
    Date Received
    March 8, 2011
    Date of Event
    February 10, 2011
    Report Date
    February 11, 2011
    Manufacturer
    AV-TEMECULA-CT
    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). EVALUATION OF THE RETURNED DEVICE FOUND THAT THE HANDLE WAS IN BACKDOWN POSITION; HOWEVER, THERE WAS SLACK ON THE SUTURES WHICH IS AN INDICATION THAT THE HANDLE WAS DEPLOYED. THERE WERE CLAMP MARKS FOUND ON THE SUTURE TUBES. THE NEEDLE SLOTS AND SUTURE PORTS APPEARED NORMAL. THERE WAS NO NEEDLE STRIKE MARK ON THE BARREL FACE. DURING TESTING, THE HANDLE WAS DEPLOYED AND ALL THE NEEDLE/SUTURES PRESENTED AT THE HUB. THE DEVICE WAS DISASSEMBLED AND MINOR COLLAPSING OF THE SUTURE TUBES WAS FOUND AT THE HUB AREA. BASED ON THE INVESTIGATION FINDINGS, THE CLAMP MARKS FOUND ON THE SUTURE TUBES AND MINOR COLLAPSING OF THE SUTURE TUBES AT THE HUB AREA IS AN INDICATION THAT A HEMOSTAT WAS APPLIED BEFORE THE NEEDLE DEPLOYMENT. CLAMPING THE SUTURE TUBE WILL INTERFERE WITH SUTURE AND NEEDLE DEPLOYMENT. THIS WILL CREATE RESISTANCE WHEN DEPLOYING THE HANDLE AND THE NEEDLES WILL NOT DEPLOY PROPERLY. THIS CONFIRMED THE REPORTED EXPERIENCE FOR THIS COMPLAINT. PER INSTRUCTIONS FOR USE UNDER DEVICE PLACEMENT AND NEEDLE DEPLOYMENT IT STATES THAT "DO NOT CLAMP THE SUTURE LUMEN WITH A HEMOSTAT OR OTHER INSTRUMENT. DOING SO WILL PREVENT THE SUTURE DEPLOYMENT." 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. NO MANUFACTURING OR QUALITY ISSUE WAS DETECTED. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. IN ADDITION, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE WERE NO SIMILAR COMPLAINTS FOR THIS LOT.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PROSTAR DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE RIGHT FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, WHEN PULLING THE HANDLE AWAY FROM THE HUB TO DEPLOY THE NEEDLES,RESISTANCE WAS FELT; THE NEEDLES DID NOT DEPLOY. HEMOSTASIS WAS SURGICALLY ACHIEVED. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. 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 930266H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention