BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RUNTHROUGH NS

    MDR report key: 5030890 · Received August 26, 2015

    Report

    Report Number
    9681834-2015-00185
    Event Type
    Injury
    Date Received
    August 26, 2015
    Date of Event
    May 7, 2015
    Report Date
    August 26, 2015
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K063695
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL SAMPLE WAS NOT RETURNED TO THE MANUFACTURING FACILITY FOR EVALUATION AND THE PRODUCT NUMBER WAS NOT PROVIDED. THEREFORE, THE CURRENT INVESTIGATION WAS BASED ON THE EVALUATION OF USER FACILITY INFORMATION AND PRODUCT SAMPLES FROM TWO POTENTIAL COMBINATIONS OF THE PRODUCT CODE AND INVOLVED LOT NUMBER. THE TWO COMBINATIONS OF PRODUCT AND LOT WERE; TW-AS418XA LOT # 150302 AND TW*DS430FH LOT#150302. VISUAL INSPECTION DID NOT FIND ANY ANOMALIES. MAGNIFYING INSPECTION OF THE PLATINUM COIL SEGMENT REVEALED NO ANOMALIES. MAGNIFYING INSPECTION OF THE STAINLESS STEEL COIL SEGMENT REVEALED NO ANOMALIES. THE OUTSIDE DIAMETERS ON THE COIL SEGMENTS WERE CONFIRMED TO BE NORMAL, MEETING THE MANUFACTURING SPECIFICATIONS. THE TENSILE STRENGTH ON THE DISTAL SEGMENT WAS DETERMINED TO BE NORMAL, MEETING THE MANUFACTURING SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD AND PRODUCT RELEASE DECISION CONTROL SHEET OF ABOVE MENTIONED PRODUCT CODE/LOT NUMBER COMBINATIONS CONFIRMED THAT THERE WERE NOT ANY INDICATIONS OF PRODUCTION-RELATED PROBLEMS OR OF NONCONFORMING INSPECTION/TEST RESULTS. A SEARCH OF THE COMPLAINT FILE DID NOT FIND ANY OTHER REPORT WITH THE MENTIONED PRODUCT/LOT NUMBER COMBINATIONS. ALTHOUGH THE EXACT CAUSE CANNOT BE DETERMINED, THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. THE DEVICE LABELING DOES ADDRESS THE POTENTIAL FOR SUCH AN EVENT IN THE INSTRUCTIONS-FOR-USE, WHICH STATES: "IF ANY RESISTANCE IS FELT OR IF THE TIP'S BEHAVIOR AND/OR LOCATION SEEMS IMPROPER, STOP MANIPULATING THE RUNTHROUGH NS AND/OR THE DILATATION CATHETER AND DETERMINE THE CAUSE BY HIGH RESOLUTION FLUOROSCOPY. FAILURE TO EXERCISE PROPER CAUTION MAY RESULT IN BENDING, KINKING, SEPARATION OF THE GUIDE WIRE'S TIP, DAMAGE TO THE DILATATION CATHETER, OR DAMAGE TO THE VESSEL. MANIPULATE THE RUNTHROUGH NS CAREFULLY WHEN CROSSING IT THROUGH A DEPLOYED STENT. STENT MIGRATION, STENT DEFORMATION OR BREAKAGE OR SEPARATION OF THE RUNTHROUGH NS MAY BE CAUSED IF THE RUNTHROUGH NS IS CAUGHT BY THE DEPLOYED STENT." (B)(4). ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP. (B)(4). ACTUAL DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    THIS REPORT IS BEING SUBMITTED IN RESPONSE TO A MEDWATCH REPORT # MW5042918 WHICH WAS RECEIVED FROM THE FDA ON 7/29/2015. THE EVENT DESCRIPTION STATES THE FOLLOWING: "DURING CORONARY ANGIOGRAPHY THE DISTAL TIP OF THE RUNTHROUGH WIRE FRACTURED AND SEPARATED IN THE PROXIMAL CIRCUMFLEX. AN ENSNARE WAS USED TO ATTEMPT TO RETRIEVE THE WIRE BUT WAS UNSUCCESSFUL. THE PATIENT BECAME UNSTABLE AND HAD A PEA ARREST. INTUBATED AND EMERGENTLY TRANSPORTED TO THE OPERATING ROOM FOR SURGERY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565301 RUNTHROUGH NS GUIDEWIRE DQX TERUMO CORPORATION, ASHITAKA NA 150302

    Patients

    Seq Age Sex Outcome Treatment
    1 Other