BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASCULAR PROBES

    MDR report key: 3892042 · Received June 24, 2014

    Report

    Report Number
    2032282-2014-00082
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    May 14, 2014
    Report Date
    June 18, 2014
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    DWP
    PMA / PMN Number
    K910682
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER MEDICAL ASSESSMENT: PARTICULATES FOUND EITHER ON OR POTENTIALLY INSIDE DEVICES THAT ARE DESIGNED TO BE UTILIZED INSIDE BLOOD VESSELS HAVE MUCH GREATER CONSEQUENCES FOR THE SURGICAL PATIENT. AS THIS DEVICE IS INTENDED TO BE USED INSIDE OF BLOOD VESSELS, PARTICULATE MATTER ON OR POTENTIALLY INSIDE THIS DEVICE HAS A POTENTIAL TO INTRODUCE THE PARTICULATE DIRECTLY INTO THE VASCULAR SYSTEM. IN A WORST CASE SCENARIO, THIS MAY LEAD TO A COMPROMISE IN BLOOD FLOW THROUGH THAT VESSEL CAUSING THROMBOSIS OR EMBOLISM. AFTER CONSIDERATION FOR POTENTIAL HARMS AND WORST-CASE SCENARIOS, AN ADVERSE HEALTH CONSEQUENCE IS EXPECTED TO RESULT FROM THIS ISSUE. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT AND EVALUATION OF THE INVESTIGATION RESULTS OF THE SAMPLE.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER (B)(4) COMPLETED THE INVESTIGATION. SAMPLE EVALUATION WAS PERFORMED. VISUAL AND STEREOMICROSCOPE INSPECTIONS OF THE SAMPLE CONFIRMED THE PRESENCE OF THE PARTICULATE MATTER. THE SAMPLES WERE FORWARDED TO BAXTER R&D BELGIUM FOR ANALYSIS, WHICH REVEALED THE PRESENCE OF A SINGLE, IRREGULAR, AND COLORLESS MASS. THE PARTICULATE MATERIAL WAS IDENTIFIED AS POLYDIMETHYLSILOXANE, WHICH WAS FIRMLY ATTACHED TO THE SIDE WALL OF THE SHUNT TAB. PER BAXTER SYNOVIS, THIS IS A MATERIAL USED TO SECURE THE KNOTS OF THE TETHER. BATCH REVIEW WAS PERFORMED AND BAXTER SYNOVIS INDICATED THAT TIER II AND TIER III BATCH RECORDS WERE REVIEWED; ALL SPECIFICATIONS AND REQUIREMENTS WERE MET PRIOR TO RELEASE OF THE PRODUCT. PER BAXTER SYNOVIS, THIS PRODUCT IS INSPECTED FOR FOREIGN MATTER AT THREE (3) POINTS DURING THE MANUFACTURING PROCESS. NO MANUFACTURING ISSUE WAS FOUND AS THE ORIGIN OF THIS COMPLAINT. THE SOURCE OF THE FOREIGN MATTER CANNOT BE DETERMINED. (B)(4) WAS CLOSED AND FOUND TO BE EFFECTIVE FOR THIS ISSUE. BAXTER SYNOVIS CONTINUES TO MONITOR THIS COMPLAINT ISSUE. NO TREND WAS IDENTIFIED. THIS COMPLAINT WILL BE KEPT ON RECORD FOR TRENDING PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A DISTRIBUTOR FROM JAPAN THAT PARTICULATE MATTER WAS FOUND IN THE INNER POUCH DURING THEIR RECEIVING INSPECTION. NO PATIENT OR USER INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368990 VASCULAR PROBES DILATOR, VESSEL, SURGICAL DWP SYNOVIS SURGICAL INNOVATIONS SPCE314-05E0020

    Patients

    Seq Age Sex Outcome Treatment
    1