BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RUNTHROUGH NS

    MDR report key: 4664014 · Received April 7, 2015

    Report

    Report Number
    9681834-2015-00059
    Event Type
    Injury
    Date Received
    April 7, 2015
    Date of Event
    March 9, 2015
    Report Date
    April 7, 2015
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K063695
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN WHICH RUNTHROUGH NS DEVICE BECAME FRACTURED, BOTH AV/PD IN #4 WERE TREATED TO PROTECT BOTH BRANCHES AND TWO RUNTHROUGHS WERE PLACED. IT WAS NOT DOCUMENTED WHICH DEVICE RECEIVED THE FRACTURE, FOR THIS REASON TWO SEPARATE MDR REPORTS WILL BE SUBMITTED. MDR REPORT # 9681834-2015-00059 FOR TW-DS418FHZ LOT# 150107 AND MDR REPORT # 9681834-2015-00052 WILL BE SUBMITTED FOR TW-AS418FAZ LOT# 150127. (B)(4) - PATIENT WITH SOME HARM, UNSPECIFIED. THE ACTUAL SAMPLE WAS NOT RETURNED TO THE MANUFACTURING FACILITY FOR EVALUATION. THEREFORE, THE INVESTIGATION WAS BASED UPON EVALUATION OF USER FACILITY INFORMATION AND THE RETENTION FROM THE REPORTED PRODUCT CODE/LOT # COMBINATION. (TW-DS418FHZ LOT# 150107). VISUAL INSPECTION ALONG THE TOTAL LENGTH FOUND NO ANOMALIES. MAGNIFYING INSPECTION OF THE PLATINUM COIL SEGMENT FOUND NO ANOMALIES. MAGNIFYING INSPECTION OF THE STAINLESS-STEEL COIL PORTION FOUND NO ANOMALIES. THE OUTSIDE DIAMETERS OF THE PLATINUM COIL AND THE STAINLESS STEEL COIL WERE VERIFIED TO MEET MANUFACTURER SPECIFICATIONS. THE HYDROPHILIC COATING WAS FULLY WETTED WITH SALINE SOLUTION AND WAS EVALUATED FOR LUBRICITY BY TACTILE FEEL. THE SAMPLE WAS CONFIRMED TO HAVE A UNIFORM APPLICATION OF HYDROPHILIC COATING AND NO LOCALIZED DECLINE IN LUBRICITY. A REVIEW OF THE DEVICE HISTORY RECORD AND THE PRODUCT RELEASE DECISION CONTROL SHEET OF THE INVOLVED PRODUCT /LOT# COMBINATION CONFIRMED THAT THERE WERE NO PRODUCTION RELATED PROBLEMS OR ANY DISCREPANCIES IN THE INSPECTION/TEST RESULTS. A REVIEW OF THE COMPLAINT FILES CONFIRMED THAT THE INVOLVED PRODUCT /LOT# COMBINATION HAS NOT BEEN REPORTED PREVIOUSLY. THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. ALTHOUGH THE EXACT CAUSE CANNOT BE DETERMINED BASED ON THE AVAILABLE INFORMATION, IT IS LIKELY THAT THE ACTUAL SAMPLE WAS CAUGHT IN ONE OF THE ALREADY IMPLANTED STENT AND THE DISTAL SEGMENT BECAME STUCK. SUBSEQUENTLY, IN THIS STATE, THE ACTUAL SAMPLE WAS SUBJECTED TO A PULLING FORCE DURING WITHDRAWAL, RESULTING IN THE FRACTURE OF THE CORE WIRE AND THE PLATINUM COIL. THE DEVICE LABELING DOES ADDRESS THE POTENTIAL FOR SUCH AN EVENT IN THE INSTRUCTIONS-FOR-USE, WHICH STATES: (1) "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, AND SEPARATION OF THE GUIDE WIRE'S TIP, DAMAGE TO THE DILATATION CATHETER, OR DAMAGE TO THE VESSEL." (2) "MANIPULATE THE RUNTHOUGHT NS CAREFULLY WHEN CROSSING IT THROUGH A DEPLOYED STENT. STENT MIGRATION, STENT DEFORMATION, OR BREAKAGE OR SEPARATION OF THE RUNTHROUHG NS MAY BE CAUSED IF THE RUNTHROUH NS IS CAUGHT BY THE DEPLOYED STENT." (3) "WHEN SELECTING THE VESSEL IN WHICH THE RUNTHOUGH NS IS TO BE INSERTED OR WHEN ADVANCING THE GUIDE WIRE THROUGH THE STENOSIS, DO NOT TURN THE PROXIMAL END OF THE GUIDE WIRE THREE OR MORE TURNS IN SUCCESSION IN THE SAME DIRECTION IF THE GUIDE WIRE'S TIP IS TRAPPED. SEPARATION OF THE GUIDE WIRE MAY RESULT." ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP. (B)(4). DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING AN OPERATION ONE OF THE TWO RUNTHROUGH NS DEVICES USED BECAME FRACTURED. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING: (1) RCA #4, AV/PD, IN THE RIGHT CORONARY WAS THE OPERATION BEING PERFORMED; (2) A MULTIPLE NUMBERS OF STENTS WERE PLACED IN #4 - #1; (3) ONE OF THE INVOLVED TWO RUNTHROUGH NS DEVICES PLACED IN THE CA PERIPHERAL BECAME FRACTURED; AND (4) IT WAS REPORTED THAT THERE WAS SOME HARM TO THE PATIENT, BUT UNSPECIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228130 RUNTHROUGH NS GUIDEWIRE DQX TERUMO CORPORATION, ASHITAKA NA 150107

    Patients

    Seq Age Sex Outcome Treatment
    1 Other