BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR?

    MDR report key: 4213559 · Received October 30, 2014

    Report

    Report Number
    3005099803-2014-03563
    Event Type
    Injury
    Date Received
    October 30, 2014
    Date of Event
    September 16, 2014
    Report Date
    September 30, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    EZB
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. 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.

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE RETURNED SENSOR GUIDEWIRE REVEALED THAT THE DISTAL TIP WAS KINKED AND DETACHED, EXPOSING THE COREWIRE TIP. THERE WERE NO EVIDENCE OF COREWIRE FRACTURE. THE OUTER DIAMETER AND GUIDEWIRE OVERALL LENGTH ARE WITHIN SPECIFICATION. BASED ON ALL GATHERED INFORMATION, THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A LABELING REVIEW WAS PERFORMED, AND FROM THE INFORMATION AVAILABLE THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSOR GUIDEWIRE WAS USED DURING A NEPHROSTOMY PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE HYDROPHILIC TIP DETACHED INSIDE THE PATIENT EXPOSING THE TIP OF THE METAL COREWIRE. AN ENDOSCOPIC ABLATION WAS DONE TO REMOVE THE DETACHED FRAGMENTS. THE PROCEDURE WAS COMPLETED WITH THIS SENSOR GUIDEWIRE. THE PATIENT HAD PROLONGED HOSPITAL STAY AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSOR GUIDEWIRE WAS USED DURING A NEPHROSTOMY PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE HYDROPHILIC TIP DETACHED INSIDE THE PATIENT EXPOSING THE TIP OF THE METAL COREWIRE. AN ENDOSCOPIC ABLATION WAS DONE TO REMOVE THE DETACHED FRAGMENTS. THE PROCEDURE WAS COMPLETED WITH THIS SENSOR GUIDEWIRE. THE PATIENT HAD PROLONGED HOSPITAL STAY AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696004 SENSOR? STYLET FOR CATHETER, GASTRO-UROLOGY EZB BOSTON SCIENTIFIC - COSTA RICA (COYOL) M0066703051 16877136

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization