BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE MARKED SPRING TIP GUIDEWIRE

    MDR report key: 17009080 · Received May 26, 2023

    Report

    Report Number
    3007305485-2023-00125
    Event Type
    Malfunction
    Date Received
    May 26, 2023
    Date of Event
    April 17, 2023
    Report Date
    June 12, 2023
    Manufacturer
    CONSOLIDATED MEDICAL EQUIPMENT COMPANY
    Product Code
    OCY
    UDI-DI
    10653405986553
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WILL NOT BE RETURNED, AND NO PHOTOGRAPHIC EVIDENCE WAS PROVIDED. THEREFORE, THE REPORTED EVENT CANNOT BE VERIFIED. THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THE PRODUCT. THE PRODUCT RELEASED FOR DISTRIBUTION WAS FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. THIS IS THE ONLY COMPLAINT FOR THIS LOT NUMBER AND FAILURE MODE WITHIN THE PAST TWO YEARS. (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING: THE GUIDEWIRE SHOULD NOT BE ADVANCED IF RESISTANCE IS MET WITHOUT DETERMINING THE CAUSE AND TAKING REMEDIAL ACTION. WE WILL CONTINUE TO MONITOR FOR TRENDS THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION AND REVIEW. HOWEVER, THE COMPLAINT INVESTIGATION IS NOT COMPLETE AT THIS TIME. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE COMPLAINT INVESTIGATION. WE WILL CONTINUE TO MONITOR FOR TRENDS THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 0

    THIS COMPLAINT WAS CREATED DUE TO THE RECEIPT OF A MEDWATCH REPORT (B)(4) ON 9MAY2023. THE CURRENT COMPLAINT DATABASE HAS BEEN RESEARCHED FOR THIS EVENT AND THERE WERE NO FINDINGS. THE REPORT WAS FOUND TO BE WRITTEN AGAINST DEVICE, DIS150, DISPOSABLE MARKED SPRING TIP GUIDEWIRE. IT WAS STATED THAT THE DEVICE WAS BEING USED DURING AN ENDOSCOPY PROCEDURE THAT OCCURRED ON (B)(6) 2023. THE REPORT STATED, "WE HAVE HAD MULTIPLE INCIDENTS WHERE CONMED DISPOSABLE GUIDE WIRES HAVE SNAPPED PARTIALLY THROUGH. THIS ISSUE HAS INVOLVED AT LEAST 2 DIFFERENT LOT NUMBERS THAT WE ARE AWARE OF." THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THERE WAS NO REPORT OF FRAGMENTATION. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Description of Event or Problem · 0

    THIS COMPLAINT WAS CREATED DUE TO THE RECEIPT OF A MEDWATCH REPORT (2300380000-2023-8017) ON (B)(6)2023. THE CURRENT COMPLAINT DATABASE HAS BEEN RESEARCHED FOR THIS EVENT AND THERE WERE NO FINDINGS. THE REPORT WAS FOUND TO BE WRITTEN AGAINST DEVICE, DIS150, DISPOSABLE MARKED SPRING TIP GUIDEWIRE. IT WAS STATED THAT THE DEVICE WAS BEING USED DURING AN ENDOSCOPY PROCEDURE THAT OCCURRED ON (B)(6)2023. THE REPORT STATED, ¿WE HAVE HAD MULTIPLE INCIDENTS WHERE CONMED DISPOSABLE GUIDE WIRES HAVE SNAPPED PARTIALLY THROUGH. THIS ISSUE HAS INVOLVED AT LEAST 2 DIFFERENT LOT NUMBERS THAT WE ARE AWARE OF.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THERE WAS NO REPORT OF FRAGMENTATION. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1915110 DISPOSABLE MARKED SPRING TIP GUIDEWIRE ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY OCY CONSOLIDATED MEDICAL EQUIPMENT COMPANY DIS150 202207294 10653405986553

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female