BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENACURE EVLT SPOTLIGHT OPS

    MDR report key: 3970282 · Received April 30, 2014

    Report

    Report Number
    1319211-2014-00059
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    December 9, 2013
    Report Date
    April 21, 2014
    Manufacturer
    ANGIODYNAMICS
    Product Code
    GEX
    PMA / PMN Number
    K031233
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RETURNED FOR EVALUATION WAS AN EVLT FIBER. A VISUAL EXAMINATION OF THE FIBER NOTED THAT THE FIBER WAS KINKED. THE COMPLAINANT'S INITIAL REPORTED COMPLAINT DESCRIPTION WAS FOR A KINKED SHEATH. UPON EXAMINATION OF THE DEVICE, THE COMPLAINT WAS VERIFIED WITH THE CUSTOMER AS A KINKED FIBER ISSUE. THE CUSTOMER'S REPORTED COMPLAINT DESCRIPTION IS CONFIRMED. A DEFINITIVE ROOT CAUSE FOR THE COMPLAINT DESCRIPTION CANNOT BE DETERMINED; HOWEVER, IT DOES NOT APPEAR TO BE MFG RELATED. THE MOST LIKELY ROOT CAUSE IS HANDLING DAMAGE AFTER THE DEVICE LEFT THE MFG FACILITY. A REVIEW OF THE LOT HISTORY RECORDS WAS PERFORMED FOR THE REPORTED LOT FOR ANY DEVIATIONS. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. DURING THE MFG PROCESS, FIBERS ARE REPEATEDLY BENT AND COILED AND THERE IS A FINAL VISUAL INSPECTION PERFORMED WITH A HENE LASER TO CHECK THE ENTIRE FIBER LENGTH FOR DEFECTS PRIOR TO PACKAGING SHIPMENT. THE EXACT ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED AT THIS TIME, ALTHOUGH IT IS UNLIKELY THAT THE KIT WAS PACKAGED WITH THE BROKEN COMPONENT. A REVIEW OF THE ANGIODYNAMICS COMPLAINT SYSTEM NOTED NO TRENDS FOR THIS COMPLAINT TYPE AND PRODUCT FAMILY. THIS TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED FOR TRENDS. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED (B)(6) 2014 A PATIENT OF UNK AGE AND GENDER PRESENTED FOR AN ENDOVENOUS LASER PROCEDURE. IT WAS REPORTED THAT WHEN OPENING THE STERILE PACKAGING DURING PREPARATION FOR THE PROCEDURE, IT WAS NOTED THAT THE DILATOR WAS KINKED IN THE PACKAGE. THE DISPOSABLE DEVICE WAS SET ASIDE AND A NEW OF THE SAME DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT DUE TO THIS EVENT AS THE DEVICE DID NOT COME INTO CONTACT WITH THE PATIENT. THE REPORTED DEVICE HAS BEEN RETURNED TO THE MFR FOR EVALUATION. AN EVALUATION OF THE RETURNED DEVICE NOTED THAT IT WAS THE FIBER THAT WAS KINKED, NOT THE DILATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258432 VENACURE EVLT SPOTLIGHT OPS ENDOVENOUS LASER TREATMENT FIBER GEX ANGIODYNAMICS 006086

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK