BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXIVA (TM) HIGH POWER SINGLE-USE LASER FIBER

    MDR report key: 3881982 · Received June 18, 2014

    Report

    Report Number
    3005099803-2014-02255
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 29, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    GEX
    PMA / PMN Number
    K100078
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE RETURNED LASER FIBER REVEALED NO EXPOSED GLASS FIBER AT THE DISTAL TIP AND THE PATTERN ON THE TIP FACE WAS CONSISTENT WITH NORMAL DEGRADATION. FUNCTIONAL ANALYSIS REVEALED THAT THE ¿ATTACH LASER FIBER¿ MESSAGE CLEARED FROM THE CONSOLE AFTER ATTACHMENT INDICATING THAT THE FIBER WAS RECOGNIZED BY THE LASER UNIT. THE AIMING BEAM EXITING THE DISTAL END OF THE FIBER WAS BRIGHT, CLEAR, AND SCATTERED WITH AN EFFECTIVE TRANSMISSION OF 83.1%. 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. A LABELING REVIEW WAS PERFORMED, AND FROM THE INFORMATION AVAILABLE THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT OF FIBER TIP DETACHED. 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

    NOTE: THIS MANUFACTURER REPORT PERTAINS TO ONE OF TWO DEVICES USED IN THE SAME PROCEDURE. REFER TO THE ASSOCIATED MANUFACTURER REPORT NUMBERS 3005099803-2014-02256 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ACCUMAX LASER FIBER AND A FLEXIVA LASER FIBER WERE USED DURING A LITHOLAPAXY PROCEDURE IN THE BLADDER PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE TIP OF THE ACCUMAX LASER FIBER BROKE OFF INSIDE THE PATIENT WHILE BREAKING UP THE BLADDER STONE AND WAS SUCCESSFULLY RETRIEVED. THE PHYSICIAN THEN ATTEMPTED TO USE A FLEXIVA LASER FIBER BUT THE TIP BROKE OFF AS WELL. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA LASER FIBER. 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

    NOTE: THIS MANUFACTURER REPORT PERTAINS TO ONE OF TWO DEVICES USED IN THE SAME PROCEDURE. REFER TO THE ASSOCIATED MANUFACTURER REPORT NUMBERS 3005099803-2014-02256 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ACCUMAX LASER FIBER AND A FLEXIVA LASER FIBER WERE USED DURING A LITHOLAPAXY PROCEDURE IN THE BLADDER PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE TIP OF THE ACCUMAX LASER FIBER BROKE OFF INSIDE THE PATIENT WHILE BREAKING UP THE BLADDER STONE AND WAS SUCCESSFULLY RETRIEVED. THE PHYSICIAN THEN ATTEMPTED TO USE A FLEXIVA LASER FIBER BUT THE TIP BROKE OFF AS WELL. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA LASER FIBER. 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
    359299 FLEXIVA (TM) HIGH POWER SINGLE-USE LASER FIBER POWERED LASER SURGICAL INSTRUMENT GEX BOSTON SCIENTIFIC - MARLBOROUGH M0068403941 ML00001901

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention