BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEFF PERCUTANEOUS ACCESS SET

    MDR report key: 2107316 · Received May 24, 2011

    Report

    Report Number
    1820334-2011-00253
    Event Type
    Injury
    Date Received
    May 24, 2011
    Date of Event
    April 26, 2011
    Report Date
    April 27, 2011
    Manufacturer
    COOK INC
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SEPARATES IS NOT SPECIFICALLY ADDRESSED, BUT BREAKAGE IS ADDRESSED ON CAUTION LABEL. INVESTIGATION RESULTS: PER SPECIFICATION, THIS DEVICE IS INSPECTED 100% FOR BENDS, KINKS, ADEQUATE JOINT STRENGTH AND OTHER SURFACE IMPERFECTIONS PRIOR TO TRANSPORT. IN ADDITION EACH WIRE GUIDE COMES WITH AN ATTACHED CAUTION LABEL, WHICH ILLUSTRATES; "WITHDRAWAL AND/OR MANIPULATION OF THE DISTAL SPRING COIL PORTION OF THE WIRE GUIDE THROUGH THE NEEDLE TIP MAY RESULT IN BREAKAGE." WITHOUT THE COMPLAINT DEVICE WE CANNOT MAKE A DEFINITE ROOT CAUSE ANALYSIS. WHEN WE HAVE SEEN THIS TYPE OF DEVICE FAILURE IN THE PAST IT HAS GENERALLY BEEN ASSOCIATED WITH THE WIRE GUIDE BEING DAMAGED BY WITHDRAWAL THROUGH THE NEEDLE (SEE WARNING LABEL) OR OTHER INSTRUMENT. LESS FREQUENTLY, PT ANATOMY MAKES WITHDRAWAL OF THE WIRE GUIDE DIFFICULT RESULTING IN SEPARATION WHEN THE FORCE EXCEEDS DESIGN SPECIFICATION. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE INTERNAL PERSONNEL.

    Description of Event or Problem · 1

    THE TIP OF THE GUIDEWIRE PROVIDED IN THE NEFF PERCUTANEOUS ACCESS SET BROKE OFF INSIDE OF THE PT. ADDITIONAL INFO RECEIVED (B)(6) 2011 (NOTES FROM THE PHYSICIAN): A (B)(6) MALE PT UNDERWENT LEFT PERCUTANEOUS NEPHROSTOMY VIA THE LEFT RETROPERITONEAL ON (B)(6) 2011 UTILIZING A COOK INCORPORATED NEFF PERCUTANEOUS ACCESS SET. PHYSICIAN WAS USING OMNIPAQUE 300 100 ML CONTRAST GIVEN INTRAVENOUSLY. SCOUT FILMS OF THE ABDOMEN WERE OBTAINED IN FRONTAL AND LATERAL PROJECTIONS. SUBSEQUENTLY, CONSECUTIVE AXIAL CT IMAGES WERE OBTAINED. THE PREVIOUSLY NOTED MILD LEFT HYDRONEPHROSIS AND LEFT URETERAL STONE WERE AGAIN DEMONSTRATED. THE PT WAS COMPARED AND DRAPED IN THE PRONE POSITION USING STERILE TECHNIQUE. ATTEMPTS TO CATHETERIZE THE LEFT RENAL COLLECTING SYSTEM WITH A NEFF INTRODUCER SET WERE UNSUCCESSFUL. DURING THE PROCEDURE THE TIP OF A MANDRIL GUIDEWIRE SEPARATED FROM THE SHAFT. CT IMAGES OBTAINED FOLLOWING THE PROCEDURE SHOW NO EVIDENCE OF BLEEDING OR FREE INTRAPERITONEAL AIR. THE DISTAL TIP OF THE GUIDEWIRE WHICH IS APPROX 24 CM IN LENGTH IS PRESENT IN THE RETROPERITONEUM. IMMEDIATELY FOLLOWING THE PROCEDURE THE PT BEGAN SHAKING. THE PT BECAME TRANSIENTLY TACHYCARDIC (A MAXIMUM OF 155 BEATS PER MIN) AND HYPERTENSIVE (A MAXIMUM OF 207/107 MM/HG). THIS IS COMPATIBLE WITH TRANSIENT SEPTICEMIA IN A PT ON DAY FIVE OF ANTIBIOTIC THERAPY FOR KNOWN URINARY TRACT INFECTION. AN RRT WAS CALLED. THE PT WAS TRANSFERRED TO THE EMERGENCY DEPARTMENT FOR EVAL. NOTES FROM EMERGENCY ROOM: THE PT WAS RECEIVED IN NO DISTRESS VIA STRETCHER ACCOMPANIED BY PT ESCORT. THE PT WAS NOTED TO HAVE A SUPRAPUBIC TUBE AND A COLOSTOMY BAG IN PLACE. THE 22 GAUGE IV ACCESS TO HIS WRIST (RIGHT) WAS INTACT. HE WAS SCHEDULED FOR A NEPHROSTOMY TUBE PLACEMENT. A (LEFT) NEPHROSTOMY TUBE PLACEMENT WAS ATTEMPTED BY A PHYSICIAN, BUT WAS UNSUCCESSFUL. THE PT WAS GIVEN A 4 MG TOTAL OF VERSED IVP AND 200 MCG OF FENTANYL IVP FOR THE PROCEDURE. HE BECAME HYPERTENSIVE AND TACHYCARDIC AT THE CLOSE OF THE PROCEDURE. THE PRIMARY ATTENDING WAS CONTACTED AND IMMEDIATELY RESPONDED. AFTER AN INITIAL ASSESSMENT, A RRT WAS CALLED. THE RRT TEAM RESPONDED IMMEDIATELY AND THE PT WAS BRIEFLY OBSERVED. WHEN IT WAS IDENTIFIED THAT THE PT WAS SAFE TO BE TRANSPORTED TO AN AREA WHERE MORE URGENT CARE COULD BE ADMINISTERED HE WAS TRANSFERRED TO THE ED VIA STRETCHER ON CARDIAC MONITOR ACCOMPANIED BY A PHYSICIAN, RN, CAN AND PT ESCORT. TIP OF WIRE GUIDE REMAINS IN THE KIDNEY. IT IS NOT DANGEROUS. THE PT WAS INFORMED AND IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEFF PERCUTANEOUS ACCESS SET DYB INTRODUCER, CATHETER DYB COOK INC NA 2556825

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other