BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS GUIDEWIRE

    MDR report key: 3931652 · Received July 14, 2014

    Report

    Report Number
    9681834-2014-00183
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 16, 2014
    Report Date
    July 14, 2014
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K863138
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT #2 IS BEING SUBMITTED TO PROVIDE THE DATE THE MANUFACTURING FACILITY RECEIVED ADDITIONAL INFORMATION REGARDING THE EVENT AND/OR EVALUATION OF THE ACTUAL SAMPLE. THIS DATE WAS INADVERTENTLY OMITTED IN THE PREVIOUS FOLLOW-UP REPORT. THE INFORMATION PROVIDED BELOW LISTS THE DATE(S) THE ADDITIONAL INFORMATION WAS RECEIVED BY THE MANUFACTURING FACILITY: FOLLOW-UP #1 = 07/10/2014.

    Additional Manufacturer Narrative · 1

    THE INVOLVED DEVICE WAS RECEIVED FOR EVALUATION BY QA AT THE MANUFACTURING FACILITY. VISUAL INSPECTION UPON RECEIPT REVEALED THE URETHANE LAYER HAD BEEN SHEARED OFF THE WIRE ON APPROXIMATELY 1235 -1328MM FROM THE DISTAL END. THE SHARED PORTION OF THE URETHANE LAYER WAS NOT RETURNED FOR EVALUATION. MAGNIFYING INSPECTION OF THE SEGMENT WHERE THE URETHANE LAYER HAD BEEN SHEARED OFF FOUND ON THE DISTAL END, THE SHEARED CROSS-SECTION WAS IN A SMOOTH STATE. THE URETHANE ON THE PROXIMAL SEGMENT APPEARED TO HAVE SCRATCHES AROUND THE SHEARED SEGMENT AND HAD BEEN ELONGATED AND RIPPED OFF. THE OUTSIDE DIAMETER WAS MEASURED ON THE INTACT SEGMENT AND CONFIRMED TO BE WITHIN THE SPECIFICATIONS, BEING COMPARABLE TO THAT OF THE NORMAL PRODUCT SAMPLE. A REVIEW OF THE DEVICE HISTORY RECORD AND SHIPPING INSPECTION RECORD INDICATED THAT THERE WERE NO PRODUCTION RELATED PROBLEMS FROM THIS LOT NUMBER. A REVIEW OF THE COMPLAINT FILES CONFIRMED THAT THIS LOT HAS NOT BEEN REPORTED PREVIOUSLY. THERE IS NO EVIDENCE THAT THE REPORTED ISSUE WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. ALTHOUGH THE CAUSE FOR THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED UPON THE AVAILABLE INFORMATION AND THE EVENT DESCRIPTION IT IS LIKELY THAT THE ACTUAL SAMPLE WAS EXPOSED TO A SHARP OBJECT, RESULTING IN A GENERATION OF A CUT ON THE URETHANE LAYER ON THE DISTAL AREA OF THE SHEARED SEGMENT. STARTING AT THE CUT, PEEL-OFF OF THE URETHANE LAYER WAS ENCOURAGED WHEN IT WAS SUBJECTED TO A SUBSEQUENT PULLING FORCE IN THE PROXIMAL DIRECTION; IT WAS ELONGATED AND RIPPED OFF, RESULTING IN THE MISSING OF THE URETHANE LAYER. 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." ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE FOR APPROPRIATE TRACKING, TRENDING, AND FOLLOW UP.

    Additional Manufacturer Narrative · 1

    THE RETURN SAMPLE FOR THIS REPORT IS CURRENTLY UNDER EVALUATION. THEREFORE, THIS INVESTIGATION WAS CONDUCTED BASED ON A REVIEW OF INFORMATION PROVIDED BY THE USER FACILITY, CURRENT PRODUCT SAMPLE, AND MANUFACTURING QUALITY RECORDS. VISUAL INSPECTION DID NOT FIND ANY ANOMALIES, SUCH AS A BREAK OR KINK. MAGNIFYING INSPECTION DID NOT REVEAL ANY ANOMALIES, INCLUDING A DENT OR FLAW. THE OUTSIDE DIAMETER WAS MEASURED ALONG THE TOTAL LENGTH AND CONFIRMED TO BE NORMAL WITHIN THE SPECIFICATIONS. THE SAMPLE WAS PEELED OFF THE URETHANE OUTER LAYER FROM THE WIRE INTENTIONALLY FOR THE PURPOSE OF CHECKING THE ADHESION LEVEL OF THE URETHANE OUTER LAYER TO THE CORE WIRE. THERE WAS NO SPACE OR ENTRAINMENT OF AIR BUBBLES BETWEEN THE CORE WIRE AND THE URETHANE OUTER LAYER. NO ANOMALIES WERE OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD AND SHIPPING INSPECTION RECORD CONFIRMED THERE WAS NO PRODUCTION RELATED PROBLEMS. A REVIEW OF THE COMPLAINT FILES CONFIRMED THAT THIS LOT NUMBER HAS NOT BEEN REPORTED PREVIOUSLY. 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 "SHEARING OF THE GLIDEWIRE ADVANTAGE, DESTRUCTION AND/OR SEPARATION OF THE OUTER POLYURETHANE COATING REQUIRING RETRIEVAL." ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE FOR APPROPRIATE TRACKING, TRENDING, AND FOLLOW UP. (B)(4). CURRENTLY UNDER EVALUATION.

    Description of Event or Problem · 1

    THIS REPORT IS BEING SUBMITTED AS FOLLOW-UP #2 FOR MFR. REPORT #9681834-2014-00183 TO PROVIDE THE DATE THAT ADDITIONAL INFORMATION WAS RECEIVED BY THE MANUFACTURING FACILITY.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED COATING MISSING FROM THE WIRE DURING A PROCEDURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: (1) ABOUT A 6 INCH PIECE OF PLASTIC JACKET COATING WAS MISSING FROM THE MIDDLE OF THE WIRE; (2) THIS WAS NOTICED DURING REMOVAL OF THE WIRE FROM THE PATIENT; (3) THE PIECE WAS NOT LEFT IN THE PATIENT; (4) A 018 COOK CXI CATHETER WAS USED; (5) CASE AND WIRE PERFORMED FINE; AND (6) THE PATIENT IS REPORTED DOING GOOD.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411111 RADIFOCUS GUIDEWIRE GLIDEWIRE DQX TERUMO CORPORATION, ASHITAKA NA 120810

    Patients

    Seq Age Sex Outcome Treatment
    1 018 COOK CXI CATHETER