BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 3965146 · Received July 29, 2014

    Report

    Report Number
    3005099803-2014-02639
    Event Type
    Injury
    Date Received
    July 29, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 9, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    GEX
    PMA / PMN Number
    K110685
    Adverse Event
    Yes
    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 THAT THE EXPOSED GLASS TIP MEASURED 1.75 MM AND APPEARED USED. 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 68.5%. SINCE THE USER CAN CONTINUE TO USE THE DEVICE AFTER A PORTION OF THE TIP BREAKS OFF, THIS WILL CHANGE THE PATTERN ON THE TIP FACE FROM ONE THAT IS CONSISTENT WITH A FRACTURE TO ONE THAT IS CONSISTENT WITH NORMAL DEGRADATION. THEREFORE, THE COMPLAINT AS REPORTED COULD NOT BE CONFIRMED. 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

    (B)(4). 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 THAT A FLEXIVA TRACTIP LASER FIBER WAS USED DURING A URETERAL LITHOTRIPSY PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE TIP OF THE LASER FIBER BROKE OFF INSIDE THE PATIENT AND WAS RETRIEVED USING A BASKET. 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

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIVA TRACTIP LASER FIBER WAS USED DURING A URETERAL LITHOTRIPSY PROCEDURE IN THE URETER PERFORMED ON (B)(6), 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE TIP OF THE LASER FIBER BROKE OFF INSIDE THE PATIENT AND WAS RETRIEVED USING A BASKET. 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
    441396 FLEXIVA (TM) TRACTIP HIGH POWER SINGLE-USE LASER FIBER POWERED LASER SURGICAL INSTRUMENT GEX BOSTON SCIENTIFIC - MARLBOROUGH M0068403961 ML00002161

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention