BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATHFINDER¿

    MDR report key: 2842017 · Received November 21, 2012

    Report

    Report Number
    3005099803-2012-05500
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    November 5, 2012
    Report Date
    December 17, 2012
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    EZB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE PATIENT'S EXACT AGE IS UNKNOWN THE PATIENT IS OVER 18 YEARS OLD. ALTHOUGH THE DEVICE HAS BEEN RETURNED FOR EVALUATION; A FAILURE ANALYSIS OF THE COMPLAINT DEVICE HAS NOT BE COMPLETED. UPON COMPLETION OF THE ANALYSIS, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE TIP OF THE GUIDEWIRE WAS BENT AND THE COIL ELONGATED. MEASUREMENTS OF THE OUTER DIAMETER REVEALED THAT GUIDEWIRE WAS WITHIN SPECIFICATION. NO DETACHMENT OF ANY PART OF THE DEVICE WERE NOTED. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT, DUE TO PROCEDURAL FACTORS MAY HAVE CAUSED THE DAMAGE ON THE DISTAL TIP DURING PROCEDURE. A DHR (DEVICE HISTORY RECORD) REVIEW WAS PERFORMED AND NO DEVIATION WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PATHFINDER GUIDEWIRE WAS USED DURING AN STONE REMOVAL PROCEDURE ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE WHEN THE PHYSICIAN TRIED TO INSERT THE GUIDEWIRE INTO A CANNULA, THE DISTAL TIP WAS NOTED TO BE ABNORMAL. THE TIP WAS SLIGHTLY BENT AND THE DISTAL COATING MATERIAL HAD DETACHED EXPOSING THE TIP OF THE GUIDEWIRE. THE DAMAGE WAS NOTED BEFORE THE GUIDEWIRE WAS INSERTED INTO THE PATIENT AND NO FRAGMENTS FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THE SAME CANNULA AND A SECOND PATHFINDER WITH NO PATIENT COMPLICATIONS. THE PATIENT'S CONDITION HAS BEEN REPORTED AS GOOD. UPDATE (B)(6) 2012: THE INVESTIGATION OF THE RETURNED DEVICE REVEALED THAT NOTHING DETACHED FROM THE GUIDEWIRE, MAKING THIS EVENT NON-REPORTABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PATHFINDER GUIDEWIRE WAS USED DURING AN STONE REMOVAL PROCEDURE ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE WHEN THE PHYSICIAN TRIED TO INSERT THE GUIDEWIRE INTO A CANNULA, THE DISTAL TIP WAS NOTED TO BE ABNORMAL. THE TIP WAS SLIGHTLY BENT AND THE DISTAL COATING MATERIAL HAD DETACHED EXPOSING THE TIP OF THE GUIDEWIRE. THE DAMAGE WAS NOTED BEFORE THE GUIDEWIRE WAS INSERTED INTO THE PATIENT AND NO FRAGMENTS FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THE SAME CANNULA AND A SECOND PATHFINDER WITH NO PATIENT COMPLICATIONS. THE PATIENT'S CONDITION HAS BEEN REPORTED AS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PATHFINDER¿ STYLET FOR CATHETER, GASTRO-UROLOGY EZB BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00551591 15136590

    Patients

    Seq Age Sex Outcome Treatment
    1