BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLO-THRU INTRALUMINAL SHUNTS

    MDR report key: 4111773 · Received September 23, 2014

    Report

    Report Number
    2032282-2014-00124
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    September 16, 2014
    Report Date
    September 16, 2014
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    DXC
    PMA / PMN Number
    K981624
    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 (INSIDE THE INNER POUCH) 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 REASONABLY 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

    COMPLAINT NO: (B)(4). BAXTER (B)(4) COMPLETED THE INVESTIGATION. SAMPLE EVALUATION WAS PERFORMED. THE SAMPLES WERE EXAMINED BOTH VISUALLY AND VIA MICROSCOPY. SAMPLE 1 CONTAINED A BLACK FIBER (3.6MM LONG) BETWEEN THE INNER AND OUTER POUCH, WHICH WAS DETERMINED TO BE EITHER COTTON OR RAYON. SAMPLE 2 CONTAINED A COLORLESS MASS ON THE EDGE OF THE TAB (APPROX. 2.5MM LONG), WHICH WAS MOST LIKELY EXCESS RTV ADHESIVE. SAMPLE 3 CONTAINED A BLACK FIBER (1.3MM LONG) ON THE TAB, WHICH WAS DETERMINED TO BE EITHER COTTON OR RAYON. SAMPLE 4 CONTAINED A BLACK PARTICLE (1.0MM X 0.75MM) BETWEEN THE INNER AND OUTER POUCH, WHICH WAS DETERMINED TO BE A PLASTIC FRAGMENT. THE COMPLAINT WAS CONFIRMED. BATCH RECORD REVIEW WAS PERFORMED AND BAXTER (B)(4) 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 (B)(4), THIS PRODUCT IS INSPECTED FOR FOREIGN MATTER AT (3) POINTS DURING THE MANUFACTURING PROCESS. NO UNITS WERE SCRAPPED OR REWORKED AT THE POUCHING OPERATION FOR FOREIGN MATTER. NO TREND WAS IDENTIFIED. BAXTER (B)(4) RECEIVED (B)(4) CUSTOMER COMPLAINTS FOR PARTICULATE MATTER (PM) DISCOVERED IN SURGICAL TOOLS PRODUCTS BETWEEN MAY 2012 AND APRIL 2013. (B)(4) OF THOSE COMPLAINTS WERE FROM A DISTRIBUTOR, (B)(4). NO PATIENTS WERE INVOLVED. (B)(4) WAS INITIATED MAY 6, 2013. CORRECTIVE ACTIONS THAT WERE IMPLEMENTED ON OR BEFORE NOVEMBER 25, 2013 DEMONSTRATED EFFECTIVENESS. AS A RESULT, (B)(4) WAS CLOSED JUNE 27, 2014. BAXTER (B)(4) HAS TEAMS IN PLACE TO MONITOR AND TAKE ACTION FOR ANY NONCONFORMANCE NOTED DURING THE MANUFACTURING PROCESS, INCLUDING THOSE RELATED TO PM. AN INVESTIGATION IS CONDUCTED BY BAXTER (B)(4) QUALITY ENGINEERING TEAM FOR EACH COMPLAINT RECEIVED. EACH COMPLAINT INVESTIGATION INCLUDES EVALUATION OF THE NONCONFORMANCE AND VERIFIES THE PRODUCT FMEA ADDRESSES THE ISSUE. IF THE ACTUAL RESULTS ARE OUTSIDE THE EXPECTED RANGES, THE FMEA IS UPDATED. A REVIEW IS THEN CONDUCTED TO DETERMINE IF A CAPA IS NECESSARY. TREND ANALYSIS IS ALSO CONDUCTED ON A QUARTERLY BASIS. ANALYSIS FROM Q2 2014 INCLUDED A STATISTICAL COMPARISON OF THE PRE-CAPA WITH POST-CAPA COMPLAINT RATES. SIGNIFICANT IMPROVEMENT WAS DEMONSTRATED. NO ACTION WAS NECESSARY. THIS COMPLAINT WILL BE KEPT ON RECORD FOR TRENDING PURPOSES. Q3 2014 STATISTICAL TREND ANALYSIS INDICATED AN INCREASE IN PM COMPLAINTS, ALL FROM ACP JAPAN. RESULTS WERE PRESENTED TO THE COMPLAINT EVALUATION TEAM ON OCTOBER 23, 2014. THE DATA WAS ESCALATED TO THE BAXTER ST. PAUL CAPA BOARD. ALTHOUGH ELEVATED, THE RATE OF COMPLAINTS HAD NOT RETURNED TO THE PREVIOUSLY HIGH RATES OBSERVED IN THE SPRING OF 2013. THE CAPA BOARD WAS CONSULTED AND ADVISED THE QUALITY ENGINEERING TEAM TO CONTINUE TO MONITOR THE COMPLAINT RATE TO DETERMINE IF THE INCREASED RATE WAS AN ANOMALY OR IF A TREND WAS PRESENT. Q4 DATA WILL BE TRENDED AND PRESENTED TO THE CAPA BOARD FOR POTENTIAL ESCALATION. THIS COMPLAINT WILL BE KEPT ON RECORD FOR TRENDING PURPOSES.

    Description of Event or Problem · 1

    REPORTED BY DISTRIBUTOR ACP: THIS PRODUCT IS A NONCONFORMING PRODUCT FOUND DURING OUR RECEIVING INSPECTION. NO PATIENT OR USER INJURY REPORTED. THE PARTICULATE MATTER WAS FOUND IN THE INNER POUCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590528 FLO-THRU INTRALUMINAL SHUNTS CLAMP, VASCULAR DXC SYNOVIS SURGICAL INNOVATIONS SPCE314-06F0016

    Patients

    Seq Age Sex Outcome Treatment
    1