BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS GLIDEWIRE

    MDR report key: 2893584 · Received January 2, 2013

    Report

    Report Number
    9681834-2013-00001
    Event Type
    Malfunction
    Date Received
    January 2, 2013
    Date of Event
    September 13, 2012
    Report Date
    September 13, 2012
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K863138
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - EVALUATION OF USER FACILITY INFORMATION & THE RETURNED SAMPLE; EVALUATION OF UNDAMAGED SECTIONS OF THE RETURNED SAMPLE CONCLUSION - EVALUATION OF USER FACILITY INFORMATION & THE RETURNED SAMPLE; EVALUATION OF UNDAMAGED SECTIONS OF THE RETURNED SAMPLE. PLEASE NOTE THAT THE USER FACILITY REPORTED BOTH 120329 AND 111104 AS POSSIBLE LOT NUMBERS BASED ON CURRENT INVENTORY. HOWEVER, THE MOST LIKELY LOT NUMBER WAS DETERMINED TO BE 120329. THE INVOLVED DEVICE WAS RECEIVED FOR EVALUATION BY QA AT THE MANUFACTURING FACILITY ON (B)(4) 2012. EXAMINATION OF THE DEVICE CONFIRMED THAT THE DEVICE HAD BEEN DAMAGED DURING USE CAUSING A "V" SHAPED CUT IN THE COATING AT APPROXIMATELY 1750-MM FROM THE DISTAL END OF THE DEVICE DIRECTLY ADJACENT TO SEVERAL OTHER AREAS OF SURFACE ABRASIONS. INSPECTION & TESTING OF UNDAMAGED SECTIONS OF THE RETURNED SAMPLE CONFIRMED THAT THERE WERE NO PRE-EXISTING DEFECTS OR ANOMALIES & PRODUCT PERFORMANCE SPECIFICATIONS WERE MET. A REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THAT THERE WERE NO PRODUCTION RELATED PROBLEMS FOR EITHER POTENTIAL LOT NUMBER. ALTHOUGH THE EXACT CAUSE CANNOT BE DETERMINED BASED ON THE AVAILABLE INFORMATION, THE APPEARANCE OF THE RETURN SAMPLE IS MOST CONSISTENT THE GUIDEWIRE HAVING BEEN DAMAGED BY A RIGID INSTRUMENT THAT WAS BEING USED DURING THE PROCEDURE, SUCH AS THE OLYMPUS SPHINCTEROTOME. THE DEVICE LABELING DOES ADDRESS THE POTENTIAL FOR SUCH AN EVENT WITH STATEMENTS IN THE WARNINGS / PRECAUTIONS SECTION OF THE INSTRUCTIONS-FOR-USE THAT INAPPROPRIATE MANIPULATION OF THE GLIDEWIRE UNDER CERTAIN CONDITIONS MAY RESULT IN DAMAGE AND/OR SEPARATION OF THE OUTER POLYURETHANE COATING. SPECIFIC STATEMENTS INCLUDE THE FOLLOWING: (1) "DO NOT MANIPULATE OR WITHDRAW THE GLIDEWIRE THROUGH A METAL NEEDLE OR A METAL DILATOR. MANIPULATION AND/OR WITHDRAWAL THROUGH A METAL ENTRY NEEDLE OR A METAL DILATOR MAY RESULT IN DESTRUCTION AND/OR SEPARATION OF THE OUTER POLYURETHANE COATING REQUIRING RETRIEVAL"; (2) "MANIPULATE THE GLIDEWIRE SLOWLY AND CAREFULLY IN THE VESSEL WHILE CONFIRMING THE BEHAVIOR AND LOCATION OF THE WIRE'S TIP UNDER FLUOROSCOPY"; AND (3) "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 FILED BY QA AT THE MANUFACTURING FACILITY FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE GUIDE WIRE BECAME "STUCK" IN AN OLYMPUS SPHINCTEROTOME DURING A PROCEDURE. NO OTHER ADDITIONAL EVENT SPECIFIC INFORMATION WAS ABLE TO BE PROVIDED BY THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430 RADIFOCUS GLIDEWIRE GUIDEWIRE DQX TERUMO CORPORATION, ASHITAKA NA 120329

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS SPHINCTEROTOME