BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 2131309 · Received June 16, 2011

    Report

    Report Number
    2024168-2011-04246
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 25, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 INVESTIGATION. 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: EVALUATION FOUND THE RETURNED DEVICE IN THE PRE-NEEDLE DEPLOYED POSITION WITH BLOOD PRESENT IN THE DEVICE. DURING TESTING, THE DEVICE MARKED WITHOUT DIFFICULTY. BASED ON THE TEST RESULTS THE REPORTED EXPERIENCE OF NOT MARKING DURING USE COULD NOT BE CONFIRMED. THE MARKER LUMEN AT THE PROXIMAL END AND THE MARKER PORT LOCATED AT THE DISTAL END WERE CLEAR WITH NO EVIDENCE OF BLOOD FLOW DETECTED. THERE WERE NO OBSTRUCTIONS, DAMAGE OR ABNORMAL OBSERVATIONS DETECTED WITH THE DEVICE THAT WOULD CONTRIBUTE TO THE REPORTED EXPERIENCE. SOME CAUSES OF THE DEVICE FAILING TO ACHIEVE MARKING ARE, BUT NOT LIMITED TO; MANUFACTURING; THE TISSUE TRACK IS NOT PROPERLY PREPARED; THE MARKER PORT POSSIBLY AGAINST THE SIDEWALL OF THE VESSEL; TISSUE MIGHT BE OBSTRUCTING THE PORT; AND THE PUNCTURE SITE MAY NOT BE IN THE COMMON FEMORAL ARTERY (PUNCTURE TOO HIGH OR LOW). TO PREVENT THIS FROM OCCURRING CONSIDER ADDITIONAL TRACT PREPARATION. WITHDRAW THE DEVICE UNTIL THE MARKER PORT IS ABOVE THE SKIN AND RE-FLUSH THE DEVICE. GENTLY ROTATE THE DEVICE, IF A SIDEWALL PUNCTURE IS SUSPECTED, KEEP ROTATING THE BARREL UNTIL PULSATILE FLOW IS ACHIEVED. BASED ON THE INVESTIGATION FINDINGS, TEST RESULTS, INSPECTION CRITERIA AND REPORTED INFORMATION, THE REPORTED FAILURE TO MARK DURING USE APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT DURING USE OF THE DEVICE AND NOT A PRODUCT QUALITY DEFICIENCY. NO MANUFACTURING OR QUALITY INSPECTION DEFICIENCY WAS DETECTED. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO PREVIOUS INCIDENTS REPORTED FOR BLOCKAGE OF THE MARKER LUMEN. 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 DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, IT WAS NOT POSSIBLE TO GET A PULSATIL BLOOD FLOW FROM THE MARKER LUMEN. THE DEVICE WAS REMOVED AND A SECOND PROSTAR WAS USED TO ACHIEVE HEMOSTASIS. 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 020076H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention