BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CATHETER

    MDR report key: 8593222 · Received May 8, 2019

    Report

    Report Number
    2021898-2019-00178
    Event Type
    Injury
    Date Received
    May 8, 2019
    Date of Event
    July 13, 2018
    Report Date
    May 8, 2019
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS AGE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE, AS THE ACTUAL AGE OF PATIENTS INVOLVED WAS NOT PROVIDED. PLEASE NOTE THAT THIS IS THE GENDER OF THE MAJORITY OF PATIENTS REPORTED IN THE ARTICLE AS THE ACTUAL GENDERS OF PATIENTS INVOLVED WAS NOT PROVIDED. PLEASE NOTE THAT THIS DATE IS BASED OFF THE DATE OF PUBLICATION OF THE ARTICLE AS THE ACTUAL EVENT DATE WAS NOT PROVIDED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADAM TUCKER,MD, MA, YOSHINAGA KAJIMOTO, MD, PHD, TOMOHISA OHMURA, MD, NAOKADO IKEDA,MD, PHD, MOTOMASA FURUSE,MD, PHD, NAOSUKE NONOGUCHI,MD, PHD, SHINJI KAWABATA,MD, PHD, TOSHIHIKO KUROIWA,MD, PHD. FLUOROSCOPIC-GUIDED PARAMEDIAN APPROACH FOR LUMBAR CATHETER PLACEMENT IN CEREBROSPINAL FLUID SHUNTING: ASSESSMENT OF SAFETY AND ACCURACY. OPERATIVE NEUROSURGERY 16 (2019). DOI: 10.1093/ONS/OPY176 BACKGROUND: SPINAL CATHETER INSERTION IN LUMBOPERITONEAL (LP) SHUNT SURGERY FOR IDIOPATHIC NORMAL PRESSURE HYDROCEPHALUS (INPH) IS F REQUENTLY ASSOCIATED WITH TECHNICAL DIFFICULTIES ESPECIALLY IN PATIENTS WITH OBESITY AND ELDERLY PATIENTS WITH VERTEBRAL DEFORMITIES. OBJECTIVE: TO ELUCIDATE THE ACCURACY AND SAFETY OF IMAGE-GUIDED SPINAL CATHETER PLACEMENT USING A PARAMEDIAN APPROACH (PMA). METHODS: WE RETROSPECTIVELY ANALYZED 39 CONSECUTIVE INPH PATIENTS TREATED BY LP SHUNTING WITH SPINAL CATHETER INSERTION VIA THE PMA. THE SUCCESS RATE OF CATHETER PLACEMENT AND THE NUMBER OF CHANGES IN PUNCTURE LOCATION WERE EVALUATED. ACCURACY OF CATHETER INSERTION WAS ASSESSED BY MEASURING BOTH VERTICAL AND HORIZONTAL DEVIATIONS IN THE POINT OF CATHETER DURAL PENETRATION FROM THE CENTER OF THE INTERLAMINAR SPACE. RESULTS: THE SUCCESS RATE OF CATHETER PLACEMENT WAS 100% (39/39). THE DIFFICULTY RATE FOR CATHETER INSERTION, MEASURED BY THE NUMBER OF CHANGES IN PUNCTURE LOCATION, WAS 2.6% (1/39). NO BLOODY PUNCTURES OR SURGICAL INFECTIONS WERE OBSERVED. ACCURACY OF CATHETER INSERTION, MEASURED AS THE DEGREE OF DEVIATION,WAS 0.5±1.9MM HORIZONTALLY AND 0.0±2.4 MM VERTICALLY. THE RATES OF MINOR COMPLICATIONS, INCLUDING CAUDAL CATHETER INSERTION, TRANSIENT LOW-PRESSURE HEADACHE, AND ROOT PAIN, WERE 5.1% (2/39), 10.4% (4/39), AND 0% (0/43), RESPECTIVELY. SUBDURAL HEMATOMA REQUIRING SURGICAL INTERVENTION OCCURRED IN 1 CASE (2.6%). DURING THE MEAN FOLLOW-UP PERIOD OF 36 MO, SPINAL CATHETER RUPTURE AT THE LEVEL OF THE SPINOUS PROCESSES WAS NOT OBSERVED. CONCLUSION: FLUOROSCOPIC-GUIDED SP INAL CATHETER PLACEMENT VIA THE PMA WAS SAFE, ACCURATE, AND RELIABLE, EVEN FOR USE IN GERIATRIC AND OBESE PATIENTS. REPORTED EVENTS. 5. POSTOPERATIVE CHRONIC SUBDURAL HEMATOMA REQUIRING OPERATION OCCURRED IN ONE CASE. THERE WAS NO CONCURRENT ADMINISTRATION OF ANTICOAGULATION MEDICATION. HOWEVER, IN THIS CASE THERE WAS A DELAY IN PERFORMING THE POSTOPERATIVE HEAD CT, AND FINDINGS AT THE TIME OF THE CT SHOWED A SIGNIFICANT SUBDURAL FLUID COLLECTION. DESPITE VALVE ADJUSTMENTS, BURR-HOLE DRAINAGE TREATMENT WAS PERFORMED. FOLLOWING THE BURR-HOLE DRAINAGE PROCEDURE, THE CHRONIC SUBDURAL HEMATOMA COMPLETELY RESOLVED, WITH SUBSEQUENT SUCCESSFUL INPH THERAPY. OF THE 41 PATIENTS IN THIS LITERATURE ARTICLE, 6 OF THE PATIENTS WERE IDENTIFIED TO HAVE THE MANUFACTURER'S DEVICE, BUT IT IS UNCLEAR WHETHER THE REPORTED EVENTS WERE INVOLVED WITH THE 6 PATIENTS THAT HAD THE MANUFACTURER'S DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384312 UNKNOWN CATHETER SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY UNKNOWN-C UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R