BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IPC® HANDPIECE - XPS® STRAIGHTSHOT HANDPIECE

    MDR report key: 8132577 · Received December 5, 2018

    Report

    Report Number
    1045254-2018-00680
    Event Type
    Injury
    Date Received
    December 5, 2018
    Date of Event
    August 1, 2018
    Report Date
    December 5, 2018
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ERL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    SAYAL, N., KEIDER, E., AND SHANT KORKIGIAN. "VISUALIZED ETHMOID ROOF CEREBROSPINAL FLUID LEAK DURING FRONTAL BALLOON SINUPLASTY". ENT-EAR, NOSE <(>&<)> THROAT JOURNAL. 97(8): E34-E38 ABSTRACT BALLOON SINUS DILATION (BSD) IS GENERALLY ACCEPTED AS A SAFE ALTERNATIVE TO TRADITIONAL SINUS SURGERY. IT IS A UNIQUE TECHNIQUE DESIGNED TO POTENTIALLY MINIMIZE COMPLICATIONS ASSOCIATED WITH TRADITIONAL FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). WE PRESENT A CASE IN WHICH A 65-YEAR-OLD MAN EXPERIENCED A CEREBROSPINAL FLUID (CSF) LEAK IN THE ETHMOID ROOF THAT WAS VISUALIZED INSTANTLY AFTER BALLOON DILATION IN A REVISION SINUS SURGERY. IN THIS CASE REPORT, WE DISCUSS THE CAUSES OF CSF LEAKS AND EXPLAIN IN DETAIL THE IMMEDIATE ENDOSCOPIC REPAIR WITH A COLLAGEN MATRIX. ALSO, LITERATURE IS REVIEWED ON THE SAFETY OF BSD VERSUS TRADITIONAL FESS. POSTOPERATIVELY, THE PATIENT HAS BEEN WITHOUT CSF LEAK AND REMAINS SYMPTOM FREE. CSF LEAK IS A RARE BUT MAJOR COMPLICATION DURING BOTH FESS AND BSD. AS BSD USE INCREASES, ITS COMPLICATION PROFILE WILL BECOME CLEARER WHEN USED ALONE, IN CONJUNCTION WITH FESS, AND/OR DURING REVISION SURGERY. ALTHOUGH BSD IS CONSIDERED A BENIGN PROCEDURE, ONE SHOULD BE CAUTIOUS WHEN USING IT IN REVISION SINUS SURGERY. REPORTED EVENT A 65-YEAR OLD MALE WITH A HISTORY OF CHRONIC SINUSITIS HAD UNDERGONE NASAL SEPTAL RECONSTRUCTION AND FUNCTIONAL ENDOSCOPIC SINUS SURGERY WITH BALLOON SINUPLASTY EXPERIENCED CEREBROSPINAL FLUID LEAK DURING THE PROCEDURE. THE PATIENT HAD PREVIOUSLY UNDERGONE SINUS SURGERY TWICE BUT SYMPTOMS INCLUDING SEVERE SINUS PRESSURE AND RHINORRHEA PERSISTED DESPITE MEDICAL THERAPY. PHYSICAL EXAMINATION SHOWED PALE, EDEMATOUS AND CRUSTED NASAL MUCOSA, SEPTAL DEVIATION TO THE RIGHT AND INFERIOR OR TURBINATE HYPERTROPHY. A PREOPERATIVE COMPUTED TOMOGRAPHY SCAN SHOWED AN INTACT CRIBIFORM PLATE AND ANTERIOR ETHMOID AIR CELLS. THE NASAL SEPTUM WAS INJECTED WITH 10 CM3 OF 1% LIDOCAINE-EPINEPHRINE SOLUTION, WITH THE LEFT SIDE ADDRESSED FIRST. THE LEFT MIDDLE TURBINATE WAS INJECTED WITH 1% LIDOCAINE-EPINEPHRINE SOLUTION, AND A FREER ELEVATOR WAS USED TO MEDIALIZE THE LEFT MIDDLE TURBINATE AFTER INJECTION. AN UNCOMPLICATED ANTROSTOMY AND ETHMOIDECTOMY PROCEDURE WAS PERFORMED WITH A POWERED MICRODEBRIDER. NEXT, A FRONTAL SINUS BALLOON WAS INTRODUCED INTO THE FRONTOETHMOIDAL RECESS ON THE LEFT SIDE. PLACEMENT WAS CONFIRMED THROUGH TRANSILLUMINATION OF THE SINUS ON THE FOREHEAD. THE SINUPLASTY BALLOON WAS THEN ADVANCED ALONG THE GUIDEWIRE AND INFLATED TO 12 CM H2O. THERE WAS LITTLE RESISTANCE WITH THE THREADING OF THE WIRE AT FIRST INFLATION. THE BALLOON WAS THEN DEFLATED, AND THEN REINFLATED TO 12 CM H2O. AFTER THE BALLOON WAS DEFLATED AND WITHDRAWN, CLEAR FLUID WAS IMMEDIATELY VISUALIZED FROM THE SITE. THE CLEAR FLUID EMANATED FROM A 2- TO 4-MM SITE AT THE ANTERIOR ETHMOID SKULL BASE JUST POSTERIOR TO THE FRONTOETHMOIDAL RECESS, INDICATING A CEREBROSPINAL FLUID LEAK. ENDOSCOPIC REPAIR WAS INITIATED WITH A COTTON PLEDGET SOAKED IN ADRENALINE USED TO INDUCE VASOCONSTRICTION. THE DEHISCENCE SITE WAS APPROXIMATELY 4 MM CIRCUMFERENTIALLY. A DUCKBILL ELEVATOR WAS USED TO STRIP MUCOSA APPROXIMATELY 5 MM SURROUNDING THE DEFECT. THE INTACT DURA WAS SEPARATED FROM THE EDGE OF THE SKULL BASE DEFECT TO ALLOW FOR AN ADEQUATE BED FOR THE STABILIZATION OF THE GRAFT. WE OPTED TO USE A COLLAGEN MATRIX FOR THIS DEFECT. THE DEFECT WAS TEMPLATED ONTO A DURAL REGENERATION MATRIX GRAFT. A SEALANT SYSTEM INJECTED OVER THE SITE SEALED THE GRAFT IN PLACE. NO FURTHER CSF DRAINAGE WAS VISUALIZED. A COLLAGEN MATRIX WAS DRAPED OVER THE MATRIX, AND GELFOAM WAS PACKED OVER THE TOP TO HELP SEPARATE THIS FROM THE NASAL PACKING THAT WAS ADDITIONALLY PLACED TO KEEP THE GRAFT IN PLACE. PERIOPERATIVE AND POSTOPERATIVE ANTIBIOTICS WERE PROVIDED. THE PATIENT WAS ADMITTED AND PLACED ON BED REST FOR 3 TO 5 DAYS WITH HEAD ELEVATION. HE WAS ASKED TO AVOID NOSE BLOWING, SNEEZING, AND STRAINING, AND STOOL SOFTENERS WERE PRESCRIBED. A DEHISCENCE OF THE LEFT CRIBRIFORM PLATE MEASURING 0.2 CM WITH ASSOCIATED LEFT PNEUMOCEPHALUS WAS DEMONSTRATED ON CT SCAN THE NEXT DAY. THE PATIENT EXHIBITED POSTSURGICAL SIGNS AND SYMPTOMS WITHOUT SUSPICIOUS HEADACHES, RHINORRHEA, VISION CHANGES, OR FRONTAL SINUS PAIN, AND WAS DISCHARGED. THE PATIENT¿S POSTOPERATIVE COURSE WAS EXCELLENT. HE WAS SYMPTOM-FREE, BOTH OF HIS PREVIOUS SINUS PRESSURE COMPLAINT AND CEREBROSPINAL FLUID LEAK. CT IMAGING 6 WEEKS LATER STILL SHOWED THE 2-MM DEFECT IN THE CRIBRIFORM PLATE, ALTHOUGH ADEQUATE SOFT TISSUE COVERED IT. IN-OFFICE SINUS ENDOSCOPY DEMONSTRATED THE DEHISCENT SITE TO BE HEALED WITHOUT EVIDENCE OF CEREBROSPINAL FLUID LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    971989 IPC® HANDPIECE - XPS® STRAIGHTSHOT HANDPIECE DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL MEDTRONIC XOMED INC. XOM UNK HPSTRSHOT NI

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Life Threatening