BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CATHETER

    MDR report key: 9583429 · Received January 13, 2020

    Report

    Report Number
    2021898-2020-00014
    Event Type
    Injury
    Date Received
    January 13, 2020
    Date of Event
    December 10, 2019
    Report Date
    January 13, 2020
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: 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

    YASUHIRO KOIDE, TAKAAKI OSAKO, MASAHIRO KAMEDA, HIROMI IHORIYA, HIROTSUGU YAMAMOTO, NORITOMO FUJISAKI, TOSHIYUKI AOKAGE, TETSUYA YUMOTO, ISAO DATE, HIROMICHI NAITO AND ATSUNORI NAKAO. HUGE ABDOMINAL CEREBROSPINAL FLUID PSEUDOCYST FOLLOWING VENTRICULOPERITONEAL SHUNT: A CASE REPORT. JOURNAL OF MEDICAL CASE REPORTS 13 (2019). DOI: 10.1186/S13256-019-2308-0. ABSTRACT INTRODUCTION: ABDOMINAL PSEUDOCYSTS COMPRISING CEREBROSPINAL FLUID ARE AN UNCOMMON BUT SIGNIFICANT COMPLICATION IN PATIENTS WITH VEN TRICULOPERITONEAL SHUNT. WE PRESENT A SUCCESSFULLY TREATED (B)(6) BOY WITH A HISTORY OF VENTRICULOPERITONEAL SHUNTING AND A HUGE ABDOMINAL CEREBROSPINAL FLUID PSEUDOCYST. CASE PRESENTATION: A (B)(6) BOY PRESENTED WITH A DETERIORATED CONSCIOUSNESS AND A PALPABLE AND ELASTIC LARGE LOWER ABDOMINAL MASS. COMPUTED TOMOGRAPHY OF HIS ABDOMEN DEMONSTRATED A COLLECTION OF HOMOGENOUS L OW-DENSITY FLUID NEAR THE CATHETER TIP OF THE VENTRICULOPERITONEAL SHUNT. CEREBRAL COMPUTED TOMOGRAPHY REVEALED AN INCREASED VENTRICULAR SIZE. BASED ON THE CLINICAL DIAGNOSIS OF ABDOMINAL PSEUDOCYST, THE PERITONEAL SHUNT CATHETER WAS SECURED AND DIVIDED INTO TWO PARTS BY CUTTING IT ON THE CHEST; THEN, THE PROXIMAL SIDE OF THE PERITONEAL SHUNT CATHETER WAS EXTERNALIZED FOR EXTRAVENTRICULAR DRAI NAGE. THE CYST WAS PERCUTANEOUSLY ASPIRATED WITH ULTRASOUND GUIDANCE, AND THE DISTAL SIDE OF THE PERITONEAL SHUNT CATHETER WAS REMOVED. THE DISTAL SIDE OF THE PERITONEAL SHUNT CATHETER WAS REINSERTED IN ANOTHER POSITION INTO HIS ABDOMEN AFTER 3-WEEK EXTRAVENTRICULAR DRAINAGE MANAGEMENT. CONCLUSION: EMERGENCY PHYSICIANS SHOULD KNOW ABOUT THIS POTENTIAL COMPLICATION AS AN IMPORTANT DIFFERENTIAL DIAGNOSIS RESULTING FROM ACUTE ABDOMINAL COMPLAINTS IN PATIENTS WITH VENTRICULOPERITONEAL SHUNTS. REPORTED EVENT. A (B)(6) BOY PRESENTED WITH COMPLAINTS OF DISTURBANCE OF CONSCIOUSNESS AND VOMITING ASSOCIATED WITH INCREASING ABDOMINAL DISTENSION STARTING 3 DAYS PRIOR TO PRESENTATION. HE COMPLAINED OF HEADACHE AND APPETITE LOSS FOR 7 DAYS. HIS PREVIOUS MEDICAL HISTORY INCLUDED REPAIR OF MYELOMENINGOCELE ON THE DAY OF HIS BIRTH; SUBSEQUENTLY, A VP SHUNT WAS PLACED FOR CONGENITAL HYDROCEPHALUS ASSOCIATED WITH SPINA BIFIDA WHEN HE WAS 10-DAYS OLD. THEREAFTER, HE UNDERWENT SEVERAL SUBSEQUENT ABDOMINAL SURGERIES FOR REINSERTION OF THE SHUNT CATHETER AND WAS FOLLOWED UP EVERY 6 MONTHS WITHOUT MEDICATION. A PHYSICAL EXAMINATION REVEALED A DETERIORATED CONSCIOUSNESS (GLASGOW COMA SCALE SCORE OF E1V2M4) AND A LARGE PALPABLE ELASTIC MASS IN HIS LOWER ABDOMEN. HIS VITAL SIGNS WERE STABLE (BLOOD PRESSURE 124/76 MMHG, HEART RATE 88 BEATS/MINUTE, BODY TEMPERATURE 36.8 °C). HIS PUPIL SIZES WERE 3MM IN EACH EYE WITH RAPID LIGHT REFLEX. LABORATORY TESTS RESULTS REVEALED AN INCREASED WHITE BLOOD CELL COUNT OF 9910/¿L (3300¿8600 /¿L) AND A C-REACTIVE PROTEIN LEVEL OF 0.54 MG/DL (<(><<)> 0.15 MG/DL). LIVER AND KIDNEY FUNCTIONS WERE NORMAL WITH NORMAL SERUM ELECTROLYTES. SERUM AMMONIA LEVEL WAS 34 ¿G/DL (30¿80 ¿G/DL). URINE ANALYSIS RESULTS WERE UNREMARKABLE. AN ABDOMINAL ULTRASOUND CONFIRMED A LARGE COLLECTION OF HOMOGENEOUS ENCYSTED FLUID ENCAPSULATING THE TIP OF THE SHUNT CATHETER. ABDOMINAL RADIOGRAPHY SHOWED THE VP SHUNT CATHETER AND THE PRESENCE OF A SOFT TISSUE MASS IN HIS UPPER ABDOMEN. CRANIAL COMPUTED TOMOGRAPHY (CT) SHOWED BILATERAL VENTRICULAR DILATION AND EFFACEMENT OF SULCI. AN ABDOMINAL CT SCAN DEMONSTRATED A 11 CM × 8 CM× 7 CM COLLECTION OF HOMOGENOUS LOW-DENSITY FLUID ADJACENT TO THE CATHETER TIP OF THE VP SHUNT. AS ABDOMINAL PSEUDOCYST ASSOCIATED WITH SHUNT MALFUNCTION WAS HIGHLY SUSPECTED AS A DIAGNOSIS, THE PROXIMAL SIDE OF THE PERITONEAL SHUNT CATHETER (STRATA® 0.5, NSC¿ VALVE, MEDTRONIC, INC., MINNEAPOLIS, MN, USA) WAS DISTALLY EXTERNALIZED FOR EXTRAVENTRICULAR DRAINAGE MANAGEMENT BY NEUROSURGERY. SUBSEQUENTLY, THE CYSTIC MASS WAS PUNCTURED THROUGH THE ABDOMINAL WALL AND 900 ML OF CLEAR FLUID WAS DRAINED. CULTURE OF THE DRAINED INTRACYSTIC FLUID WAS NEGATIVE FOR MICROORGANISMS, WITH PROTEIN 36 IU/L AND GLUCOSE 71MG/DL. THE LEUKOCYTE AND ERYTHROCYTE COUNTS WERE 0 AND 2/¿L, RESPECTIVELY. THE DISTAL SIDE OF THE PERITONEAL SHUNT CATHETER WAS REMOVED FROM HIS ABDOMINAL CAVITY. PROPHYLACTIC CEFAZOLIN SODIUM 3 GRAMS/DAY WAS ADMINISTERED FOR 3 DAYS POSTOPERATIVELY. A FOLLOWUP BRAIN CT TAKEN 3 DAYS POSTOPERATIVELY REVEALED NO INCREASE IN VENTRICULAR SIZE. THE SHUNT CATHETER WAS REINSERTED TO ANOTHER POSITION IN HIS ABDOMEN 3 WEEKS LATER. HE FULLY RECOVERED WITH NO FURTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47095 UNKNOWN CATHETER SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY UNKNOWN-C UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Hospitalization| R