BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUSTICK¿ II

    MDR report key: 5131413 · Received October 7, 2015

    Report

    Report Number
    2134265-2015-06784
    Event Type
    Injury
    Date Received
    October 7, 2015
    Date of Event
    September 11, 2015
    Report Date
    September 14, 2015
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    DYB
    PMA / PMN Number
    K952828
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: RECEIVED ONE .018" GUIDEWIRE WITH NO VISIBLE RESIDUE FOUND ON THE DEVICE. AN EXAMINATION OF THE GUIDEWIRE FOUND THE CORE WIRE TO BE BROKEN AT APPROXIMATELY 50.5 CM FROM THE PROXIMAL (STIFF) END. THE DISTAL PORTION, INCLUDING THE COIL WIRE AND CORE WIRE WAS NOT RETURNED. THE GUIDEWIRE WAS BENT AT APPROXIMATELY 31.5 CM FROM THE PROXIMAL END. THE CORE WIRE WAS EXAMINED UNDER MAGNIFICATION AND IT WAS FOUND TO BE BENT AND FRACTURED NEAR THE TRANSITION. THE FRACTURE SURFACE SHOWS EVIDENCE OF FAILING WHILE UNDERGOING TENSILE AND/ OR BENDING STRESS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE GUIDEWIRE FRACTURED. THE PHYSICIAN SELECTED AN ACCUSTICK II INTRODUCER SHEATH TO PERFORM A NEPHROSTOMY PROCEDURE IN THE KIDNEY. THE MANDREL WIRE FROM THE FIRST KIT HAD A SLIGHT KINK IN IT BEFORE USE BUT LOOKED SUFFICIENTLY OK AND THE PHYSICIAN DECIDED TO USE IT. ACCESS TO THE KIDNEY WAS FIRST ATTEMPTED IN THE LOWER POLE WITH DIFFICULTY ENTERING THE KIDNEY, NOT IDEALLY POSITIONED FOR A DRAIN. IT WAS DECIDED TO LEAVE THE ACCESS NEEDLE AND MANDREL WIRE IN THE PATIENT UNTIL A SECOND ACCESS WAS MADE WITH ANOTHER ACCUSTICK II INTRODUCER SHEATH. THE SECOND KIT WAS ABLE TO BE PLACED IN THE CORRECT LOCATION FOR DRAIN PLACEMENT. WHEN THE FIRST MANDREL WIRE WAS REMOVED IT SNAPPED LEAVING APPROXIMATELY 7CM OF THE TIP IN THE PATIENT'S KIDNEY. THERE WAS NO FORCE APPLIED WHEN REMOVING THE WIRE AND NEEDLE TOGETHER. THE PATIENT IS UNDER REVIEW WITH A FAINT CHANCE THE WIRE MAY HAVE TO BE SURGICALLY REMOVED, BUT THE HEAD OF DEPARTMENTS OPINION, IS THAT IT WILL NOT AFFECT THE WORKING OF THE KIDNEY. NO FURTHER COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE GUIDEWIRE FRACTURED.THE PHYSICIAN SELECTED AN ACCUSTICK II INTRODUCER SHEATH TO PERFORM A NEPHROSTOMY PROCEDURE IN THE KIDNEY. THE MANDREL WIRE FROM THE FIRST KIT HAD A SLIGHT KINK IN IT BEFORE USE BUT LOOKED SUFFICIENTLY OK AND THE PHYSICIAN DECIDED TO USE IT. ACCESS TO THE KIDNEY WAS FIRST ATTEMPTED IN THE LOWER POLE WITH DIFFICULTY ENTERING THE KIDNEY, NOT IDEALLY POSITIONED FOR A DRAIN. IT WAS DECIDED TO LEAVE THE ACCESS NEEDLE AND MANDREL WIRE IN THE PATIENT UNTIL A SECOND ACCESS WAS MADE WITH ANOTHER ACCUSTICK II INTRODUCER SHEATH. THE SECOND KIT WAS ABLE TO BE PLACED IN THE CORRECT LOCATION FOR DRAIN PLACEMENT. WHEN THE FIRST MANDREL WIRE WAS REMOVED IT SNAPPED LEAVING APPROXIMATELY 7CM OF THE TIP IN THE PATIENT'S KIDNEY. THERE WAS NO FORCE APPLIED WHEN REMOVING THE WIRE AND NEEDLE TOGETHER. THE PATIENT IS UNDER REVIEW WITH A FAINT CHANCE THE WIRE MAY HAVE TO BE SURGICALLY REMOVED, BUT THE HEAD OF DEPARTMENTS OPINION, IS THAT IT WILL NOT AFFECT THE WORKING OF THE KIDNEY. NO FURTHER COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662620 ACCUSTICK¿ II INTRODUCER, CATHETER DYB BOSTON SCIENTIFIC - SPENCER M001207030 17802665

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention