BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIVA (TM) TRACTIP HIGH POWER SINGLE-USE LASER FIBER

    MDR report key: 4243839 · Received November 11, 2014

    Report

    Report Number
    3005099803-2014-03638
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 14, 2014
    Report Date
    October 24, 2014
    Manufacturer
    MEDVENTURE TECHNOLOGY CORPORATION
    Product Code
    GEX
    PMA / PMN Number
    K110685
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE RETURNED LASER FIBER REVEALED FIBER WAS RECEIVED BROKEN IN TWO PIECES. THE INVESTIGATOR FOUND THAT THE FIBER BROKE 55.5 CM FROM THE DISTAL TIP. THE EXPOSED GLASS TIP OF THE LASER FIBER MEASURED 3.0 MM AND APPEARED USED. THE PATTERN ON THE TIP FACE WAS CONSISTENT WITH A FRACTURE INDICATING THAT THE TIP OR PORTION OF THE TIP WAS DETACHED. THE NOTED DAMAGES INDICATE DIFFICULTY WAS EXPERIENCED DURING USE OF THE LASER FIBER AND ARE LIKELY DUE TO ANATOMICAL OR PROCEDURAL FACTORS SUCH AS MANEUVERING OF THE DEVICE OR STONE DENSITY AND SIZE. THEREFORE, THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT OF FIBER BROKE. THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS; HOWEVER, THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2014 THAT A FLEXIVA TRACTIP 200 LASER FIBER WAS USED DURING A URETEROSCOPY WITH STONE EXTRACTION PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE LASER FIBER BODY BROKE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2014 THAT A FLEXIVA TRACTIP 200 LASER FIBER WAS USED DURING A URETEROSCOPY WITH STONE EXTRACTION PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE LASER FIBER BODY BROKE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726321 FLEXIVA (TM) TRACTIP HIGH POWER SINGLE-USE LASER FIBER POWERED LASER SURGICAL INSTRUMENT GEX MEDVENTURE TECHNOLOGY CORPORATION M0068403961 ML00002525

    Patients

    Seq Age Sex Outcome Treatment
    1