BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8/10 DILATOR/SHEATH SET

    MDR report key: 4170315 · Received October 14, 2014

    Report

    Report Number
    3005099803-2014-03370
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    September 25, 2014
    Report Date
    September 25, 2014
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    EZN
    PMA / PMN Number
    K851144
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE RETURNED RENAL DILATOR STYLET AND SHEATH REVEALED THAT THE DISTAL TIP OF THE SHEATH WAS SPLIT AND DEFORMED AND THE SHEATH WAS KINKED IN SEVERAL LOCATIONS. THE STYLET WAS BENT MOST LIKELY DUE TO THE WAY IT WAS PACKAGED FOR RETURN. 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 SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN 8/10 DILATOR/SHEATH SET WAS USED DURING A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DISTAL TIP OF THE DILATOR WAS DETACHED INSIDE THE PATIENT UPON ADVANCING THE INTRO NEEDLE AND WAS SUCCESSFULLY RETRIEVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER 8/10 DILATOR/SHEATH SET. 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 STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN 8/10 DILATOR/SHEATH SET WAS USED DURING A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DISTAL TIP OF THE DILATOR WAS DETACHED INSIDE THE PATIENT UPON ADVANCING THE INTRO NEEDLE AND WAS SUCCESSFULLY RETRIEVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER 8/10 DILATOR/SHEATH SET. 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 STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649530 8/10 DILATOR/SHEATH SET DILATOR, CATHETER, URETERAL EZN BOSTON SCIENTIFIC - SPENCER M0062601200 16757239

    Patients

    Seq Age Sex Outcome Treatment
    1