BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PGW .018 SV SHORT 180CM ST

    MDR report key: 6050486 · Received October 24, 2016

    Report

    Report Number
    1016427-2016-00095
    Event Type
    Malfunction
    Date Received
    October 24, 2016
    Date of Event
    August 24, 2016
    Report Date
    November 22, 2016
    Manufacturer
    LAKE REGION
    Product Code
    DQX
    PMA / PMN Number
    K930091
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING RECORD (DHR) REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE PER THE APPLICABLE MANUFACTURING QUALITY PLAN. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    DURING AN ANGIOGRAPHIC PROCEDURE, THE PHYSICIAN NOTICED THE DISTAL TIP OF THE 180 CM. PGW SV SHORT ST GUIDEWIRE COMING OFF. THE PHYSICIAN WITHDREW THE GUIDEWIRE BACK INTO THE DIAGNOSTIC CATHETER WHERE IT WAS NOTED THAT THE TIP OF THE GUIDEWIRE WAS NOT DISLODGED. THERE WAS NO REPORTED PATIENT INJURY. ONE NON-STERILE PGW .018 SV SHORT 180CM ST WAS RECEIVED COILED INSIDE A PLASTIC BAG. ALSO, A 5FR DIAGNOSTIC CATHETER WAS RECEIVED. THE CORE DISTAL SECTION OF THE WIRE WAS FRACTURED; THE COIL WIRE WAS UNRAVELED\STRETCHED AND WAS ALSO FRACTURED APPROXIMATELY AT THE SAME PLACE THAN THE CORE WIRE. NO OTHER ANOMALIES WERE OBSERVED ON THE RECEIVED PRODUCT. SEM ANALYSIS RESULTS SHOWED THAT THE SEPARATED THE GUIDE WIRE CORE AND THE COIL WIRE INDUCED TO TENSION CONDITIONS WHERE THE SEPARATED METAL PRESENTED EVIDENCE PLASTIC DEFORMATION OF DUCTILE DIMPLES AND STRESS LINES. PLASTIC DEFORMATION FAILURES COULD BE RELATED TO THESE SURFACE CHARACTERISTICS, THESE TYPES OF FAILURES OCCUR DUE TO A TENSILE, COMPRESSION OR TORSION OVERLOAD. ALSO DUCTILE DIMPLES SUGGEST THAT STRETCHING / PULLING EVENTS WERE OCCURRED. LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF THE ABOVE MENTIONED LOT. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. THE REPORTED FAILURE OF ¿DISTAL TIP-WIRES- FRACTURED-IN PATIENT¿ WAS CONFIRMED FROM PRODUCT ANALYSIS. THE EXACT CAUSE OF THE REPORTED FAILURE COULD NOT BE CONCLUSIVELY DETERMINED. BASED ON THE INFORMATION AVAILABLE FOR REVIEW, PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE SEPARATION AS EVIDENCED BY THE DUCTILE DIMPLES AND STRESS LINES DURING ANALYSIS. AS WARNED IN THE INSTRUCTIONS FOR USE (IFU): ¿GUIDEWIRES ARE DELICATE INSTRUMENTS AND SHOULD BE HANDLED CAREFULLY. PRIOR TO USE AND WHEN POSSIBLE DURING THE PROCEDURE, INSPECT THE GUIDEWIRE CAREFULLY FOR COIL SEPARATION, BENDS, OR KINKS. DO NOT USE A GUIDEWIRE THAT SHOWS SIGNS OF DAMAGE. DAMAGE WILL PREVENT THE GUIDEWIRE FROM PERFORMING WITH ACCURATE TORQUE RESPONSE AND CONTROL.¿ ACCORDING TO THE PRODUCT IFU¿S, USERS ARE WARNED TO NEVER ADVANCE, WITHDRAW OR AUGER THE GUIDEWIRE AGAINST RESISTANCE WITHOUT FIRST DETERMINING THE CAUSE OF RESISTANCE UNDER FLUOROSCOPY. TORQUING THE GUIDEWIRE AGAINST RESISTANCE MAY CAUSE DAMAGE AND/OR FRACTURE WHICH MAY RESULT IN SEPARATION OF THE DISTAL TIP. WITH THE INFORMATION AVAILABLE AND WITHOUT FILMS OF THE EVENT, IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE REPORTED EVENT. NEITHER THE DEVICE HISTORY RECORD NOR THE PRODUCT ANALYSIS SUGGESTS THAT THE EVENT COULD BE RELATED TO THE GUIDEWIRE DESIGN OR MANUFACTURING PROCESS; THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED, DURING AN ANGIOGRAPHIC PROCEDURE, THE PHYSICIAN NOTICED THE DISTAL TIP OF THE 180 CM. PGW SV SHORT ST GUIDEWIRE COMING OFF. THE PHYSICIAN WITHDREW THE GUIDEWIRE BACK INTO THE DIAGNOSTIC CATHETER WHERE IT WAS NOTED THAT THE TIP OF THE GUIDEWIRE WAS NOT DISLODGED. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT IS NOT BEING RETURNED FOR INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702169 PGW .018 SV SHORT 180CM ST ENDOVASCULAR WIRES & METALS (DQX) DQX LAKE REGION 503558 35229027

    Patients

    Seq Age Sex Outcome Treatment
    1