BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN CATHETER

    MDR report key: 8592957 · Received May 8, 2019

    Report

    Report Number
    2021898-2019-00177
    Event Type
    Malfunction
    Date Received
    May 8, 2019
    Date of Event
    July 13, 2018
    Report Date
    May 8, 2019
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. UNINTENDED CAUDAL INSERTION OF THE SPINAL CATHETER WAS OBSERVED IN 2 CASES (5.1%). HOWEVER, IN THESE CASES, CAUDAL INSERTION WAS NOT ASSOCIATED WITH SHUNT DYSFUNCTION OR ROOT PAIN. POSTOPERATIVE POSITIONAL HEADACHE WAS OBSERVED IN 4 CASES (10.4%). HOWEVER, HEADACHE SYMPTOMS IN ALL 4 PATIENTS ALMOST FULLY RESOLVED WITHIN 1 WK WITHOUT THE NEED FOR ANY ADDITIONAL TREATMENT. IN 5 CASES (12.8%), THE INTERVERTEBRAL SPACE LEVEL OF CATHETER INSERTION DID NOT MATCH THE INTENDED INSERTION LEVEL. 2 CATHETERS RUPTURED AT THE TRANSITION SITE BETWEEN THE LUMBAR MUSCULAR FASCIA AND THE SUBCUTANEOUS FATTY TISSUE, POSSIBLY BECAUSE OF MANUAL LUMBAR MASSAGE OR TRAUMATIC IMPACT DUE TO FALLING. 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
    385411 UNKNOWN CATHETER SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY UNKNOWN-C UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR