Shunt failure due to intracranial migration of BioGlide ventricular catheters

Hsin-Hung Chen1, Jay Riva-Cambrin, Douglas L Brockmeyer

  • 1Department of Neurosurgery, Neurological Institute, Taipei Veterans General Hospital, Taiwan, Republic of China.

Abstract

Insights

Bio-Glide Snap Shunt catheters can disconnect, leading to serious complications and recall. Early detection through specific imaging is crucial for managing this ventriculoperitoneal shunt failure.

Area of Science:

  • Neurosurgery
  • Biomedical Engineering
  • Medical Device Safety

Background:

  • Ventriculoperitoneal shunts are critical for treating hydrocephalus.
  • The Bio-Glide Snap Shunt ventricular catheter was introduced with a novel snap-design.
  • A specific failure mode, catheter disconnection, was identified.

Purpose of the Study:

  • To investigate a novel failure mode of Bio-Glide Snap Shunt ventricular catheters.
  • To report on the incidence, clinical presentation, and management of catheter disconnections.
  • To inform clinical practice and patient safety regarding this device.

Main Methods:

  • Retrospective review of patient cohort implanted with Bio-Glide Snap Shunt catheters.
  • Identification of index cases and subsequent case finding.
  • Notification of the Food and Drug Administration (FDA) leading to product recall.
  • Patient communication via letters, a dedicated call center, and an informational website video.
  • Review of medical records and imaging (CT scans) for identified cases.

Main Results:

  • Twenty-three cases of catheter disconnection were identified in 466 implanted catheters.
  • Mean time to disconnection was 2.7 years, with a wide range.
  • Computed tomography (CT) imaging in the plane of the catheter aided visualization.
  • Catheter retrieval was challenging; in 5 cases, removal was not possible.
  • Four children experienced severe neurological deficits, and one patient died due to shunt malfunction.

Conclusions:

  • Bio-Glide snap-design ventricular catheters exhibit a propensity for disconnection.
  • Vigilance and specialized imaging techniques are essential for diagnosing disconnections.
  • Management of disconnected catheters can be complex, with potential difficulties in removal.
  • The efficacy of elective prophylactic removal in asymptomatic patients remains unstudied.

Related Concept Videos