BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RUNTHROUGH NS

    MDR report key: 6629132 · Received June 9, 2017

    Report

    Report Number
    9681834-2017-00113
    Event Type
    Injury
    Date Received
    June 9, 2017
    Date of Event
    April 9, 2017
    Report Date
    June 9, 2017
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K063695
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL DEVICE WAS NOT RETURNED TO THE MANUFACTURING FACILITY FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. FOR THIS REASON, EVALUATION CODE 20 HAS BEEN REFERENCED IN THE CONCLUSIONS SECTION OF H6. THE LOT NUMBER IS UNKNOWN FOR THE REPORT COMPLAINT. BASED ON SALES DISTRIBUTION, THE FOLLOWING LOT NUMBERS ARE POTENTIAL LOT NUMBERS FOR THE INVOLVED PRODUCT CODE. 170210, 170215 AND 170221. D4: UDI- THE LOT NUMBER IS UNKNOWN FOR THE REPORTED PRODUCT CODE, HOWEVER, THE UDI NUMBERS ARE PROVIDED FOR THE POTENTIAL REPORTED LOT NUMBERS FOR THE REPORTED PRODUCT CODE. 25-1011/170210: (01)04987350779373(17)200131(10)170210 25-1011/170215: (01)04987350779373(17)200131(10)170215 25-1011/170221: (01)04987350779373(17)200131(10)170221 REVIEW OF DEVICE HISTORY RECORDS AND THE SHIPPING INSPECTION RECORDS OF THE ABOVE POTENTIAL PRODUCT CODE /LOT# COMBINATIONS WAS CONDUCTED WITH NO RELEVANT FINDINGS. A REVIEW OF THE INVOLVED SHIPPING INSPECTION RECORDS FOCUSING ON THE DEVICE DISTAL SEGMENT'S FRACTURE RESISTANCE TEST RESULTS CONFIRMED THERE WAS NO INDICATION OF ANOMALY WITH THE POTENTIALLY INVOLVED THREE LOT NUMBERS. WITH THE LOT NUMBERS BEFORE AND AFTER THE INVOLVED THREE LOT NUMBERS (DURING THE TIME PERIOD FROM NOVEMBER, 2016 TO MAY 2017), THERE WAS NO INDICATION OF SIGNIFICANT/SPECIFIC VARIATION IN THE DATA. A SEARCH OF THE COMPLAINT FILE FOUND NO OTHER REPORT WITH THE ABOVE POTENTIAL PRODUCT CODE/LOT# COMBINATIONS. WITH NO RETURN OF THE ACTUAL SAMPLE TO EVALUATE THE DEFINITIVE CAUSE OF THIS COMPLAINT CANNOT BE DETERMINED. BASED ON THE COMPLAINT DESCRIPTION, IT IS ASSUMABLE THAT THE DISTAL COIL SEGMENT OF THE ACTUAL SAMPLE WAS TRAPPED IN A HARD OBJECT, INCLUDING THE CALCIFIED LESION AND IN THIS STATE, IT WAS SUBJECTED TO AN EXCESSIVE PULLING FORCE, RESULTING IN THE REPORTED FRACTURE OF THE SHAFT. THE DEVICE LABELING DOES ADDRESS THE POTENTIAL FOR SUCH AN OCCURRENCE IN THE INSTRUCTION FOR USE (IFU) WITH THE STATEMENT SUCH AS THE FOLLOWING: "IF ANY RESISTANCE TO THE RUNTHROUGH NS OR THE DILATATION CATHETER IS FELT DURING MANIPULATION OR IF THE SHAPE, BEHAVIOR OR POSITION OF THE GUIDE WIRE'S TIP SEEMS IMPROPER, E.G., IN A CASE WHERE THE TIP IS TRAPPED DUE TO VESSEL SPASM OR SOME OTHER CAUSE OR THE TIP IS FOLDED, STOP MANIPULATING THE GUIDE WIRE (AND THE CATHETER) AND DETERMINE THE CAUSE CAREFULLY BY FLUOROSCOPY AND TAKE SUITABLE REMEDIAL ACTIONS. THEN REMOVE THE GUIDE WIRE SLOWLY, WITHOUT TURNING, TO EXCHANGE IT FOR A NEW ONE. CONTINUING GUIDE WIRE OR CATHETER MANIPULATION IN THE SAID SITUATION MAY RESULT IN DAMAGE TO THE VESSEL, DAMAGE TO OR SEPARATION OF THE GUIDE WIRE'S TIP, AND/OR DAMAGE TO THE DILATATION CATHETER." TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834. EXEMPTION NUMBER E2015022. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP. H3 OTHER TEXT : DEVICE NOT AVAILABLE

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED BREAKAGE OF THE INVOLVED GUIDEWIRE DEVICE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: SHAPED RUNTHROUGH WITH FINGERS AND CROSSED THE CALCIFICATION WITH RUNTHROUGH; THE WIRE GOT STUCK THROUGH THE CALCIFICATION IN THE LAD AND SECOND DIAGONAL; THE DOCTOR WAS UNABLE TO REMOVE WIRE; TRIED TO BALLOON AND SNARE TO RELEASE THE WIRE; AFTER NUMEROUS SUCCESSFUL ATTEMPTS AND CONSULTATION WITH COLLEAGUES, THEY HAD NO CHOICE BUT TO PULL OR TUG ON THE WIRE TO REMOVE, AND AT THAT POINT THE WIRE SHEARED AND BROKE AWAY; SURGICAL INTERVENTION WAS THEN REQUIRED; AND THE DOCTOR STATED THE WIRE BREAKAGE WAS NOT THE ULTIMATE CAUSE OF DEATH FOUR WEEKS POST OPERATION ON 5/9/2017. ADDITIONAL INFORMATION WAS REPORTED ON 5/11/2017. OPEN HEART SURGERY WAS PERFORMED. NONE OF THE BROKEN WIRE PIECES WERE ABLE TO BE FOUND.

    Additional Manufacturer Narrative · 1

    RETENTION SAMPLES FROM THE REPORTED PRODUCT CODE WITH THE FOLLOWING LOT NUMBERS WERE EVALUATED. LOT NUMBER 170210, LOT NUMBER 170215 AND LOT NUMBER 170221. VISUAL INSPECTION REVEALED NO DEFECTS. THE PLATINUM COIL SEGMENT ON 0MM - APPROXIMATELY 30MM FROM THE DISTAL END OF THE DEVICE WAS INSPECTED UNDER MAGNIFICATION AND WAS CONFIRMED NOT TO HAVE ANY ANOMALY, SUCH AS JUMBLING OR ELONGATION IN THE COILING OR WIDENED COIL PITCH. THE STAINLESS COIL SEGMENT WAS INSPECTED UNDER MAGNIFICATION AND WAS CONFIRMED NOT TO HAVE ANY ANOMALY, SUCH AS JUMBLING OR ELONGATION IN THE COILING OR WIDENED COIL PITCH. THE OUTSIDE DIAMETERS WERE DETERMINED ON THE COILED SEGMENTS AND CONFIRMED TO MEET MANUFACTURER SPECIFICATIONS. THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. THE EXACT CAUSE CANNOT BE DEFINITIVELY DETERMINED BASED ON THE INVESTIGATION FINDINGS. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411698 RUNTHROUGH NS WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA 25-1011 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other| R