BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CATHETER

    MDR report key: 21635147 · Received March 18, 2025

    Report

    Report Number
    9612164-2025-01379
    Event Type
    Injury
    Date Received
    March 18, 2025
    Date of Event
    January 5, 2025
    Report Date
    March 18, 2025
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    SHI HUI ONG, AUDREY JIA LUAN TAN, LEANNE QIAOJING TAN, NIVEDH DINESH, BOLEM NAGARJUN, TSENG TSAI YEO, VINCENT DIONG WENG NGA. IMPROVEMENT IN OUTCOMES WITH ULTRASOUND-GUIDED VENTRICULOPERITONEAL SHUNT INSERTION. JOURNAL OF CLINICAL NEUROSCIENCE 133 (2025). DOI: 10. 1016/J.JOCN.2024.111018. ABSTRACT: VENTRICULOPERITONEAL SHUNT (VPS) INSERTION IS A NEUROSURGICAL PROCEDURE DONE ROUTINELY FOR MANAGING HYDROCEPHALUS. HOWEVER, THE TECHNIQUE OF SHUNT INSERTION REMAINS CONTROVERSIAL. IN THIS STUDY, WE RETROSPECTIVELY COMPARED THE ACCURACY OF SHUNT PLACEMENT USING ULTRASOUND (US) GUIDANCE TO FREEHAND INSERTION. OUR SECONDARY AIM WAS TO EXPLORE THE LEARNING CURVE OF USING US TO GUIDE VPS INSERTION. THIS STUDY INCLUDED 220 PATIENTS WHO UNDERWENT VPS PLACEMENT BETWEEN JANUARY 2018 TO DECEMBER 2021 AT A SINGLE-CENTERED TERTIARY HOSPITAL. 201 ADULTS AND 19 PEDIATRIC PATIENTS WERE RECRUITED INTO THE STUDY. MOST COMMON CAUSES OF HYDROCEPHALUS INCLUDE POST-SUBARACHNOID HEMORRHAGE (23.2 %), TUMOR (24.5 %), AND POST INTRACRANIAL BLEED (16.8 %). ACCURACY OF SHUNT PLACEMENT WAS DETERMINED BY EVALUATING THE LOCATION OF THE SHUNT CATHETER TIP IN THE FIRST POST-OPERATIVE IMAGING AND THE SHUNT REVISION RATE. RATES OF OPTIMALLY PLACED AND FUNCTIONING SHUNTS WERE HIGHER UNDER US GUIDANCE (79.5 % VS 50.6 %) COMPARED TO FREEHAND INSERTION (P = 0.01). RATES OF SHUNT REVISION WITHIN 30 DAYS WERE STATISTICALLY HIGHER IN FREEHAND VPS INSERTION (5.7 % VS0.0 %) COMPARED TO US-GUIDED PLACEMENT EVEN AFTER PROPENSITY-MATCHED ANALYSIS (P = 0.02). THERE WAS NO STATISTICAL DIFFERENCE IN ACCURACY BETWEEN SHUNTS PLACED BY CONSULTANTS AND RESIDENTS IN THE US COHORT (P = 0.71). IN CONCLUSION, OUR STUDY REINFORCES THE BENEFIT OF US-GUIDED VPS INSERTION. PATIENTS WHO UNDERWENT US-GUIDED VPS INSERTION HAD STATISTICALLY SIGNIFICANT IMPROVEMENT IN SHUNT ACCURACY AND LOWER SHUNT REVISION RATE. THE LEARNING CURVE FOR SURGEONS TO ADOPT US GUIDANCE IN VPS INSERTION IS LESS STEEP THAN THOUGHT. REPORTED EVENTS: POST-OPERATIVELY, THE MOST COMMON SHUNT COMPLICATION NECESSITATING SHUNT REVISION WITHIN 30 DAYS WAS SHUNT MALFUNCTION SECONDARY TO OBSTRUCTION IN THE FREEHAND COHORT (26.1 %) COMPARED TO NO SHUNT RELATED COMPLICATION IN THE US COHORT (0 %). THE ETIOLOGIES OF SHUNT OBSTRUCTION INCLUDED INTRACRANIAL BLEED (33.3 %), SPACE OCCUPYING LESIONS SUCH AS TUMOR OR CYST (33.3 %) AND INFECTION (33.3 %). IN ADDITION, 4 (17.4 %) SHUNTS WERE FOUND TO BE MALPOSITIONED IN THE FREEHAND COHORT. THERE WERE NO SHUNT RELATED INFECTIONS IN BOTH COHORTS, WITHIN 30 DAYS. POST-OPERATIVELY, THE MOST COMMON SHUNT COMPLICATION NECESSITATING SHUNT REVISION AFTER 30 DAYS WAS SHUNT MALFUNCTION SECONDARY TO OBSTRUCTION IN THE FREEHAND COHORT (34.8 %) COMPARED TO THE US COHORT (100 %). IN ADDITION, 5 (21.7%) SHUNTS WERE FOUND TO OVERDRAIN IN THE FREEHAND COHORT COMPARED TO NONE INT HE US COHORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573362 UNKNOWN CATHETER SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC IRELAND UNKNOWN-C UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H