BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE GUIDEWIRE

    MDR report key: 5376135 · Received January 19, 2016

    Report

    Report Number
    9681834-2015-00274
    Event Type
    Malfunction
    Date Received
    January 19, 2016
    Date of Event
    October 27, 2015
    Report Date
    January 19, 2016
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K091417
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BE SUBMITTED AS FOLLOW-UP # 1 FOR MFG. REPORT # 9681834-2015-00274 TO PROVIDE UPDATED INFORMATION. THE LOT NUMBER WAS INITIALLY REPORTED AS UNKNOWN. THE LOT NUMBER WAS DETERMINED TO BE 140822 AND THE EXPIRATION DATE IS 07/31/2016. THE REPORT WILL BE UPDATED WITH THE MANUFACTURING DATE, 08/22/2014. A REVIEW OF THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE INVOLVED PRODUCT/LOT# COMBINATION WAS CONDUCTED WITH NO RELEVANT FINDINGS. A REVIEW OF THE COMPLAINT FILE DID NOT FIND ANY OTHER REPORT WITH THE INVOLVED PRODUCT CODE/LOT# COMBINATION. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP.

    Additional Manufacturer Narrative · 1

    RESULTS IS BASED ON EVALUATION OF USER FACILITY INFORMATION & THE RETURNED SAMPLE; UPON EVALUATION OF UNDAMAGED SECTIONS OF THE RETURNED SAMPLE. CONCLUSION IS BASED UPON EVALUATION OF USER FACILITY INFORMATION & THE RETURNED SAMPLE; UPON EVALUATION OF UNDAMAGED SECTIONS OF THE RETURNED SAMPLE. THE ACTUAL DEVICE WAS RETURNED TO THE MANUFACTURING FACILITY FOR EVALUATION AND THE LOT NUMBER IS UNKNOWN. VISUAL INSPECTION UPON RECEIPT REVEALED THAT THE OUTER URETHANE LAYER ON THE ACTUAL SAMPLE HAD BEEN SHEARED OFF. MAGNIFYING INSPECTION REVEALED THAT SOME CRACKS AND ABRASIONS HAD BEEN GENERATED ON THE URETHANE LAYER. ELECTRON MICROSCOPIC INSPECTION REVEALED THAT THE SURFACE OF THE DAMAGED SEGMENTS, INCLUDING THE COIL AND THE URETHANE LAYER, HAD BECOME ROUGH. THE KINK RESISTANCE OF THE SHAFT WAS DETERMINED AND CONFIRMED TO MEET MANUFACTURER SPECIFICATION. THE OUTSIDE DIAMETER WAS MEASURED ON THE UNDAMAGED SEGMENT AND CONFIRMED TO MEET MANUFACTURER SPECIFICATION. THE PRODUCTION LOT NUMBER WAS NOT PROVIDED BY THE USER FACILITY, WHICH PREVENTED A MEANINGFUL REVIEW OF PRODUCTION AND COMPLAINT RECORDS. THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION AND THE EXACT CAUSE CANNOT BE DETERMINED BASED ON THE AVAILABLE INFORMATION FROM THE USER FACILITY AND INVESTIGATION RESULTS. IT IS LIKELY THAT THE ACTUAL SAMPLE WAS SUBJECTED TO EXTERNAL FORCES, INCLUDING PULLING AND COMPRESSING FORCES. BY THESE FORCES, THE URETHANE LAYER MAY HAVE BEEN SHEARED OFF AND THE INTERMEDIATE TUBE MAY HAVE DRIFTED IN THE DISTAL DIRECTION. THE DEVICE LABELING DOES ADDRESS THE POTENTIAL FOR SUCH AN EVENT BY STATING IN THE INSTRUCTIONS-FOR-USE (IFU) "IF ANY RESISTANCE IS FELT OR IF THE TIP'S BEHAVIOR AND/OR LOCATION SEEMS IMPROPER, STOP MANIPULATING THE GUIDE WIRE AND/OR ENDOTHERAPY ACCESSORY AND DETERMINE THE CAUSE BY FLUOROSCOPY OR ENDOSCOPE. CONTINUING TO MANIPULATE THE GUIDE WIRE COULD CAUSE PATIENT INJURY, SUCH AS PUNCTURES, HEMORRHAGES OR MUCOUS MEMBRANE DAMAGE. IT MAY ALSO DAMAGE THE ENDOSCOPE, INSTRUMENT AND/OR ENDOTHERAPY ACCESSORY". (B)(4). ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP.

    Description of Event or Problem · 1

    THIS REPORT IS BE SUBMITTED AS FOLLOW-UP # 1 FOR MFG. REPORT # 9681834-2015-00274 TO PROVIDE UPDATED INFORMATION. THE LOT NUMBER WAS INITIALLY REPORTED AS UNKNOWN. THE LOT NUMBER WAS DETERMINED TO BE 140822 AND THE EXPIRATION DATE IS 07/31/2016. REPORT WILL BE UPDATED WITH THE MANUFACTURING DATE, 08/22/2014.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THE COATING PEELED OFF WHEN THE ACTUAL SAMPLE WAS INSERTED INTO THE PAPILLOTON GW LUMEN USING THE VIGIGLIDE DEVICE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY REPORTED THE FOLLOWING INFORMATION: (1) NO IMPACT TO THE PATIENT. THREE COMPLAINT SAMPLES FROM THE SAME REPORTED PRODUCT CODE WERE REPORTED. SEE MDR# 9681834-2015-00272 AND MDR# 9681834-2015-00273.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35315 SINGLE USE GUIDEWIRE CATHETER DQX TERUMO CORPORATION, ASHITAKA NA 140822

    Patients

    Seq Age Sex Outcome Treatment
    1