BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RUNTHROUGH NS

    MDR report key: 4213531 · Received October 30, 2014

    Report

    Report Number
    9681834-2014-00283
    Event Type
    Injury
    Date Received
    October 30, 2014
    Date of Event
    October 3, 2014
    Report Date
    October 30, 2014
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K063695
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVOLVED DEVICE WAS RETURNED TO THE MANUFACTURING FACILITY FOR EVALUATION. VISUAL INSPECTION UPON RECEIPT FOUND THE DISTAL EXTREMITY OF THE CORE WIRE HAD BEEN FRACTURED AND WAS MISSING BY APPROXIMATELY 8MM IN LENGTH. THE PLATINUM COIL HAD BEEN FRACTURED AND WAS MISSING BY APPROXIMATELY 30MM IN LENGTH. THE CORE WIRE WAS EXPOSED BY APPROXIMATELY 28MM IN LENGTH. MAGNIFYING INSPECTION REVEALED THE CORE WIRE HAD BEEN DISTORTED TOWARD THE DISTAL END. ELECTRON MICROSCOPIC INSPECTION OF THE FRACTURE CROSS-SECTION REVEALED THAT BOTH THE CORE WIRE AND THE PLATINUM COIL HAD FRACTURED AS THE RESULT OF HAVING BEEN EXPOSED TO SOME TORSION FORCES. SIMULATION TESTING WAS CONDUCTED. A TEST SAMPLE WAS TRAPPED IN THE PHANTOM VESSEL AT THE DISTAL SEGMENT. IN THIS STATE, THE SAMPLE WAS SUBJECTED TO REPETITIVE TORQUE FORCES IN ONE-WAY DIRECTIONS. THE SAMPLE WAS THEN WITHDRAWN. A RESULT, THE CORE WIRE GOT FRACTURED APPROXIMATELY 10MM FROM THE DISTAL END AND THE PLATINUM COIL AT APPROXIMATELY 30MM FROM THE DISTAL END. A REVIEW OF THE DEVICE HISTORY RECORD AND PRODUCT RELEASE DECISION CONTROL SHEET CONFIRMED THAT THERE WERE NO PRODUCTION RELATED PROBLEMS FOR THIS PRODUCT/LOT# COMBINATION. A REVIEW OF THE COMPLAINT FILE CONFIRMED THAT THIS PRODUCT/LOT# 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 BECAME STUCK IN THE EXISTING STENT AND THEN, IN THIS STATE, IT WAS SUBJECTED TO SOME REPETITIVE ONE-WAY TORQUE MANIPULATIONS, RESULTING IN THE GENERATION OF THE FRACTURES ON THE CORE WHILE AND PLATINUM COIL. THE DEVICE LABELING DOES ADDRESS THE POTENTIAL FOR SUCH AN EVENT IN THE WARNINGS / PRECAUTIONS SECTION OF THE INSTRUCTIONS FOR-USE BY STATEMENTS SUCH AS THE FOLLOWING: (1) "MANIPULATE THE GLIDEWIRE SLOWLY AND CAREFULLY IN THE VESSEL WHILE CONFIRMING THE BEHAVIOR AND LOCATION OF THE WIRE'S TIP UNDER FLUOROSCOPY"; AND (2) "IF ANY RESISTANCE IS FELT, OR IF THE TIPS BEHAVIOR AND/OR LOCATION SEEMS IMPROPER, STOP MANIPULATING THE GLIDEWIRE AND/OR THE CATHETER AND DETERMINE THE CAUSE BY FLUOROSCOPY. FAILURE TO EXERCISE PROPER CAUTION MAY RESULT IN BENDING, KINKING, SEPARATION OF THE GUIDEWIRE'S TIP, DAMAGE TO THE CATHETER, OR DAMAGE TO THE VESSEL". ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP.

    Additional Manufacturer Narrative · 1

    THE ACTUAL SAMPLE WAS NOT RETURNED TO THE MANUFACTURING FACTORY FOR EVALUATION. RESERVE SAMPLE FORM THE SAME PRODUCT CODE/LOT NUMBER COMBINATION HAS BEEN EVALUATED. VISUAL INSPECTION DID NOT FIND ANY ANOMALIES OR DEFECTS. MAGNIFYING INSPECTION OF THE PLATINUM COIL SEGMENT AND STAINLESS STEEL COIL SEGMENT ALSO DID NOT REVEAL ANY ANOMALIES OR DEFECTS. FUNCTIONAL TESTING CONFIRMED ALL PERFORMANCE SPECIFICATIONS WERE MET. A REVIEW OF THE DEVICE HISTORY AND SHIPPING INSPECTION RECORDS CONFIRMED THAT THERE WERE NO PRODUCTION RELATED PROBLEMS FOR THIS PRODUCT CODE LOT NUMBER COMBINATION. A REVIEW OF THE COMPLAINT FILES CONFIRMED THAT THIS LOT NUMBER HAS NOT BEEN REPORTED PREVIOUSLY. ALTHOUGH THE EXACT CAUSE CANNOT BE DETERMINED BASED ON THE AVAILABLE INFORMATION, 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 WARNINGS / PRECAUTIONS SECTION OF THE INSTRUCTIONS-FOR-USE BY STATEMENTS SUCH AS THE FOLLOWING: (1) "MANIPULATE THE GLIDEWIRE SLOWLY AND CAREFULLY IN THE VESSEL WHILE CONFIRMING THE BEHAVIOR AND LOCATION OF THE WIRE'S TIP UNDER FLUOROSCOPY"; AND (2) "IF ANY RESISTANCE IS FELT, OR IF THE TIPS BEHAVIOR AND/OR LOCATION SEEMS IMPROPER, STOP MANIPULATING THE GLIDEWIRE AND/OR THE CATHETER AND DETERMINE THE CAUSE BY FLUOROSCOPY. FAILURE TO EXERCISE PROPER CAUTION MAY RESULT IN BENDING, KINKING, SEPARATION OF THE GUIDEWIRE'S TIP, DAMAGE TO THE CATHETER, OR DAMAGE TO THE VESSEL." ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP. (B)(4). DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A PROCEDURE, THE TIP SEPARATED FROM THE WIRE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING: (1) THE DOCTOR PLACED A STENT IN LAD AND ATTEMPTED TO CROSS THROUGH THE STENT STRUTS TO BALLOON ANGIOPLASTY THE DIAGONAL BRANCH; (2) THE WIRE WENT DISTAL TO THE BRANCH DOWN THE LAD WHERE IT APPEARED TO HOOK AROUND A STENT STRUT; (3) THE DOCTOR MADE MANY ATTEMPTS TO DISLODGE THE WIRE FROM BEHIND THE STENT; (4) THE DOCTOR USED A FINECROSS AND GUIDELINER TO LEND SUPPORT TO THE WIRE BUT WAS UNSUCCESSFUL; (5) THE DOCTOR PULLED ON THE WIRE AND THE TIP SEPARATED FROM THE WIRE; (6) THE DOCTOR THEN TACKED UP THE TIP USING ANOTHER STENT TO "JAIL" THE TIP TO THE WALL OF THE VESSEL; (7) TO CONFIRM SUCCESS, OCT WAS USED TO MAKE SURE THERE WAS VESSEL LUMEN INTEGRITY; (8) THE PROCEDURE WAS COMPLETED; AND (9) THE PATIENT'S CONDITION IS REPORTED AS "GOOD".

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694954 RUNTHROUGH NS GLIDEWIRE DQX TERUMO CORPORATION, ASHITAKA NA 140714

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other GUIDELINER| FINECROSS