BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSEND EX 014/205 FLOPPY

    MDR report key: 8725322 · Received June 21, 2019

    Report

    Report Number
    3008853977-2019-00052
    Event Type
    Malfunction
    Date Received
    June 21, 2019
    Date of Event
    June 16, 2019
    Report Date
    August 26, 2019
    Manufacturer
    BOSTON SCIENTIFIC COSTA RICA
    Product Code
    DQX
    UDI-DI
    08714729326250
    PMA / PMN Number
    K944677
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. DURING THE ANALYSIS OF THE RETURNED DEVICE, IT WAS REVEALED THAT THE GUIDEWIRE WAS FRACTURED AND BENT. IN ADDITION, THE GUIDEWIRE PTFE (POLYTETRAFLUOROETHYLENE) COATING WAS SCRAPED. FUNCTIONAL ANALYSIS WAS NOT BE PERFORMED DUE TO THE ANOMALIES FOUND ON THE PRODUCT. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER INDICATED THAT THE DEVICE WAS PREPARED PER THE DFU (DIRECTION FOR USE). FROM THE CONDITION OF THE GUIDEWIRE, THE ANOMALIES ON THE DEVICE APPEAR TO BE THE RESULT OF EXCESSIVE MANIPULATION. ADDITIONALLY, BECAUSE THIS COMPLAINT APPEARS TO BE ASSOCIATED WITH HANDLING OF THE PRODUCT OR PORTION OF THE PRODUCT DURING THE PROCEDURE A PROBABLE CAUSE OF HANDLING DAMAGE WAS ASSIGNED TO THE REPORTED AND ANALYZED GUIDEWIRE BROKEN/FRACTURED INSIDE PATIENT, AND THE ANALYZED GUIDEWIRE KINKED/BENT. THE TORQUE DEVICE WAS NOT RETURNED WITH THE GUIDEWIRE, SO THE CAUSE OF THE PTFE COATING PEELING COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    DURING ANEURYSM EMBOLIZATION, THE PHYSICIAN COULD NOT ADVANCE THE GUIDEWIRE (SUBJECT DEVICE) IN THE MICROCATHETER. THE GUIDEWIRE AND MICROCATHETER WERE REMOVED AND THE PHYSICIAN FOUND THE GUIDEWIRE HAD BROKEN. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE IS NOT AVAILABLE.

    Description of Event or Problem · 1

    DURING ANEURYSM EMBOLIZATION, THE PHYSICIAN COULD NOT ADVANCE THE GUIDEWIRE (SUBJECT DEVICE) IN THE MICROCATHETER. THE GUIDEWIRE AND MICROCATHETER WERE REMOVED AND THE PHYSICIAN FOUND THE GUIDEWIRE HAD BROKEN. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518146 TRANSEND EX 014/205 FLOPPY WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC COSTA RICA 22299901 08714729326250

    Patients

    Seq Age Sex Outcome Treatment
    1 SL-10 (STRYKER)| SL-10 (STRYKER)