BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUNTHROUGH NS GUIDEWIRE

    MDR report key: 3053369 · Received April 11, 2013

    Report

    Report Number
    9681834-2013-00037
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 13, 2013
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K063695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - BASED UPON EVALUATION OF USER FACILITY INFORMATION & THE RETURNED SAMPLE; 213 IS BASED UPON TESTING OF RESERVE SAMPLE AND UNDAMAGED SECTIONS OF THE RETURNED SAMPLE CONCLUSIONS - BASED UPON EVALUATION OF USER FACILITY INFORMATION & THE RETURNED SAMPLE; BASED UPON TESTING OF RESERVE SAMPLE AND UNDAMAGED SECTIONS OF THE RETURNED SAMPLE SUBSEQUENT TO SUBMISSION OF THE INITIAL MEDWATCH REPORT, THE INVOLVED DEVICE WAS RETURNED TO THE MANUFACTURING FACILITY FOR EVALUATION. VISUAL EXAMINATION OF THE RETURNED SAMPLE REVEALED THAT: THE SHAFT OF THE DEVICE HAD BEEN KINKED AT APPROXIMATELY 1.5MM AND 7.25MM FROM THE DISTAL END; THE CORE WIRE HAD BEEN FRACTURED AT APPROXIMATELY 10MM FROM THE DISTAL END; AND THE PLATINUM COIL WIRE HAD BEEN STRETCHED, FRACTURED AND SEPARATED FROM THE CORE WIRE. EVALUATION OF UNDAMAGED SECTIONS OF THE RETURNED DEVICE CONFIRMED NO EVIDENCE OF ABNORMALITIES OR DEFECTS. EXAMINATION OF A RESERVE SAMPLE FROM THE REPORTED LOT CONFIRMED NO EVIDENCE OF ABNORMALITIES OR DEFECTS. FUNCTIONAL TESTING ON A RESERVE SAMPLE FROM THE REPORTED LOT CONFIRMED ALL PERFORMANCE SPECIFICATIONS WERE MET. 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, THE APPEARANCE OF THE INVOLVED SAMPLE IS MOST CONSISTENT WITH THE GUIDE WIRE HAVING BEEN DAMAGED BY CONTINUED MANIPULATION AFTER THE DISTAL PORTION HAD BECOME TRAPPED OR CAUGHT ON SOMETHING WITHIN THE PATIENT'S VESSEL DURING THE PROCEDURE EVENTUALLY RESULTING IN THE OBSERVED FRACTURE OF THE CORE WIRE, PLUS UNRAVELING, AND THEN, FRACTURE OF THE PLATINUM COIL WIRE. THE DEVICE LABELING DOES ADDRESS THE POTENTIAL FOR SUCH AN EVENT IN THE WARNINGS / PRECAUTIONS SECTION OF THE INSTRUCTIONS-FOR-USE BY STATEMENTS INCLUDING: "IF ANY RESISTANCE IS FELT OR IF THE TIPS 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"; AND "WHEN USING A DRUG OR A DEVICE CONCURRENTLY WITH THE RUNTHROUGH NS, THE OPERATOR SHOULD HAVE A FULL UNDERSTANDING OF THE PROPERTIES/CHARACTERISTICS OF THE DRUG OR DEVICE SO AS TO AVOID DAMAGE TO THE RUNTHROUGH NS." ALL CURRENTLY AVAILABLE INFORMATION HAS BEEN PLACED ON FILE BY QA AT THE MANUFACTURING FACILITY FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP.

    Additional Manufacturer Narrative · 1

    THE INVOLVED DEVICE HAS NOT BEEN RETURNED FOR EVALUATION SO THE CAUSE FOR THE REPORTED ELONGATION OF THE WIRE CANNOT BE CONFIRMED. INSPECTION AND TESTING OF A RETAINED SAMPLE FROM THE REPORTED LOT DID CONFIRM THAT THERE WERE NO ANOMALIES OR DEFECTS AND PERFORMANCE SPECIFICATIONS WERE MET. A REVIEW OF THE DEVICE HISTORY RECORD INDICATED THAT THERE WERE NO PRODUCTION RELATED PROBLEMS. A REVIEW OF THE COMPLAINT FILES CONFIRMED THAT THIS LOT NUMBER HAS NOT BEEN REPORTED PREVIOUSLY. ALTHOUGH THE CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED, THERE IS NO INDICATION THAT THERE WAS ANY RELATION TO A DEFECT OR MALFUNCTION OF THE DEVICE. THE POTENTIAL FOR SUCH AN EVENT IS ADDRESSED IN THE WARNINGS / PRECAUTIONS SECTION OF THE INSTRUCTIONS-FOR-USE BY STATEMENTS SUCH AS THE FOLLOWING: "IF ANY RESISTANCE IS FELT OR IF THE TIPS 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"; "WHEN USING A DRUG OR A DEVICE CONCURRENTLY WITH THE RUNTHROUGH NS, THE OPERATOR SHOULD HAVE A FULL UNDERSTANDING OF THE PROPERTIES/CHARACTERISTICS OF THE DRUG OR DEVICE SO AS TO AVOID DAMAGE TO THE RUNTHROUGH NS"; AND "DO NOT MANIPULATE THE RUNTHROUGH NS THROUGH THE STENT STRUTS. SUCH MANIPULATIONS MAY CAUSE THE RUNTHROUGH NS HYDROPHILIC POLYMER COATING TO PEEL OFF, AND DAMAGE AND/OR SEVER THE WIRE". ALL CURRENTLY AVAILABLE INFORMATION HAS BEEN FILED BY QA AT THE MANUFACTURING FACILITY FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING SUBMITTED AS FOLLOW-UP # 1 FOR MFG. REPORT # 9681834-2013-00037 TO PROVIDE ADDITIONAL INFORMATION REGARDING EVALUATION OF THE RETURNED SAMPLE.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE TIP OF THE GUIDEWIRE BECAME "ELONGATED" WHILE THE DEVICE WAS BEING USED DURING AN ANGIOPLASTY PROCEDURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: THE TIP OF THE WIRE ELONGATED DURING THE PROCEDURE AND A SNARE WAS USED TO ATTEMPT TO REMOVE THE DEVICE; THE DEVICE WAS SUCCESSFULLY REMOVED AFTER BEING CAUGHT ON THE IVUS CATHETER; THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT; THE ORIGINAL PROCEDURE WAS COMPLETED SUCCESSFULLY; AND THE PATIENT IS REPORTED TO BE "FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155001 RUNTHROUGH NS GUIDEWIRE GUIDEWIRE DQX TERUMO CORPORATION, ASHITAKA NA 120925

    Patients

    Seq Age Sex Outcome Treatment
    1 BALLOON STENT IVUS