BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PGW .018 SV SHORT 300CM ST

    MDR report key: 14745870 · Received June 20, 2022

    Report

    Report Number
    1016427-2022-05410
    Event Type
    Malfunction
    Date Received
    June 20, 2022
    Date of Event
    May 26, 2022
    Report Date
    July 26, 2022
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DQX
    UDI-DI
    10705032056069
    PMA / PMN Number
    K930091
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 0

    AS REPORTED, THE WIRE TIP OF AN SV-5 STEERABLE GUIDEWIRE (PGW .018 SV SHORT 300CM ST) CAME OUT OF PACKAGE FRAYED AND UNRAVELED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS NOT USED IN THE PATIENT THE PRODUCT WAS STORED AS PER LABELING. THE DAMAGE WAS NOTICED DURING PREP. THE TIP OF THE WIRE WAS STRETCHED AND UNRAVELED WHEN THE DEVICE WAS TAKEN OUT OF THE PACKAGE. THERE WAS NO DAMAGE NOTICED TO THE DEVICE PRIOR TO OPENING THE PACKAGE NOR ANY DIFFICULTY ENCOUNTERED REMOVING THE DEVICE FROM THE STERILE PACKAGING. THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU) WITHOUT DIFFICULTY. A NON-STERILE GUIDEWIRE ¿PGW .018 SV SHORT 300CM ST¿ WAS RECEIVED FOR ANALYSIS. DURING VISUAL INSPECTION, THE RADIOPAQUE DISTAL COIL WIRE WAS NOTED TO BE UNRAVELED. NO OTHER DAMAGES OR ANOMALIES WERE OBSERVED ON THE RETURNED UNIT. THE DISTAL TIP WAS ANALYZED USING A VISION SYSTEM TO MAGNIFY THE DAMAGED AREA. THE PROXIMAL TIP OF THE COIL WIRE IS ATTACHED TO THE CORE WIRE. THE UNRAVELING OF THE COIL WIRE RESULTED IN THE EXPOSURE OF THE GUIDEWIRE CORE WIRE. THE DISTAL CORE WIRE IS FRACTURED/SEPARATED IN TWO PARTS AND THE SEPARATED DISTAL SECTION WAS RETURNED ATTACHED TO THE DISTAL PART OF THE COIL WIRE. SEM ANALYSIS RESULTS CONFIRMED A FRACTURED/SEPARATED CONDITION WITH THE CORE WIRE NOTED TO BE SEPARATED INTO TWO PIECES. THE SEPARATED PORTION OF THE WIRE WAS RETURNED FOR ANALYSIS. RESULTS PRESENTED EVIDENCE OF PLASTIC DEFORMATION ON THE DAMAGED AREAS OF THE UNIT. A PRODUCT HISTORY RECORD (PHR) REVIEW OF LOT 35264195 REVEALED NO ANOMALIES OR NON-CONFORMANCES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED EVENT. THE FAILURE REPORTED BY THE CUSTOMER AS ¿DISTAL TIP-WIRES-FRAYED/SPLIT/TORN-DURING PREP¿ WAS NOT CONFIRMED. NO FRAYED/SPLIT/TORN CONDITION WAS OBSERVED ON THE DISTAL TIP. THE FAILURE REPORTED BY THE CUSTOMER AS ¿DISTAL TIP-WIRES- UNRAVELED/STRETCHED - DURING PREP¿ WAS CONFIRMED, THE DISTAL TIP PRESENTS WITH AN UNRAVELED CONDITION. THE EVENT ¿DISTAL TIP-WIRES- FRACTURED-SEPARATED - DURING PREP¿ WAS CONFIRMED. THE CORE WIRE WAS RETURNED SEPARATED IN TWO PIECES. THE PLASTIC DEFORMATIONS NOTED ALONG THE DAMAGED AREA IS EVIDENCE OF MATERIAL TENSILE OVERLOAD. THEREFORE, IT IS ASSUMED THAT THE MATERIAL OF THE WIRE WAS INDUCED TO A TENSILE FORCE THAT EXCEEDED THE WIRE MATERIAL YIELD STRENGTH PRIOR TO THE FRACTURE/SEPARATION. THE EXACT CAUSE OF THESE DAMAGES COULD NOT BE CONCLUSIVELY DETERMINED DURING THE ANALYSIS. PULLING ON THE DISTAL TIP TO REMOVE THE GUIDEWIRE FROM THE DISPENSER TUBE IS A COMMON CAUSE OF THESE OBSERVED DAMAGES. USERS ARE TRAINED TO INSPECT FOR SIGNS OF DAMAGE PRIOR TO AND DURING USE. ANY PRODUCT WITH DAMAGE IS NOT TO BE USED. INFORMATION FOR SAFETY IS PROVIDED IN THE PRODUCTS LABELING WITH THE INTENT TO MAKE THE USER AWARE OF THE RISKS. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), ALTHOUGH NOT INTENDED AS A MITIGATION OF RISK, ¿OPEN THE STERILE PACKAGE SLOWLY. TO PREVENT DAMAGE TO THE DISTAL TIP OF THE GUIDEWIRE AND TO PREVENT THE GUIDEWIRE FROM SPRINGING ONTO A NON-STERILE FIELD, CAREFULLY REMOVE THE GUIDEWIRE FROM THE DISPENSING TUBE. USE THE DISPENSER WINDOW TO ADVANCE THE GUIDEWIRE DISTAL TIP, SUCH THAT THE GUIDEWIRE CAN BE REMOVED BY GRASPING THE COATED SHAFT. NOTE: DO NOT PULL THE DISTAL TIP TO REMOVE GUIDEWIRE FROM DISPENSER AS IT MAY DAMAGE THE TIP.¿ BASED ON THE INFORMATION AVAILABLE AND THE PHR REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE DESIGN OR MANUFACTURING PROCESS. THEREFORE, NO PREVENTATIVE OR CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 0

    AS REPORTED, THE WIRE TIP OF AN SV-5 STEERABLE GUIDEWIRE (PGW .018 SV SHORT 300CM ST) CAME OUT OF PACKAGE FRAYED AND UNRAVELED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS NOT USED IN THE PATIENT THE PRODUCT WAS STORED AS PER LABELING. THE DAMAGE WAS NOTICED DURING PREP. THE TIP OF THE WIRE WAS STRETCHED AND UNRAVELED WHEN THE DEVICE WAS TAKEN OUT OF THE THE PACKAGE. THERE WAS NO DAMAGE NOTICED TO THE DEVICE PRIOR TO OPENING THE PACKAGE NOR ANY DIFFICULTY ENCOUNTERED REMOVING THE DEVICE FROM THE STERILE PACKAGING. THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU) WITHOUT DIFFICULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2042711 PGW .018 SV SHORT 300CM ST WIRE, GUIDE, CATHETER DQX CORDIS CORPORATION 503558X 35264195 10705032056069

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown