OBJECT: In late 2008, the authors recognized a new type of ventriculoperitoneal shunt failure specific to the Bio-Glide Snap Shunt ventricular catheters. This prompted a retrospective review of the patient cohort and resulted in a recall by the FDA in the US. METHODS: After the index cases were identified, the FDA was notified by the hospital, leading to a recall of the product. Hospital operative logs were used to identify patients in whom the affected products were used. A letter describing the risk was sent to all patients offering a free screening CT scan to look for disconnection. A call center was established to respond to patient questions, and an informational video was made available on the hospital website. The authors reviewed the records of the index cases and other cases subsequently identified. RESULTS: Seven index cases and an additional 16 cases of disconnection were identified in the 466 patients in whom a BioGlide Snap Shunt ventricular catheter had been implanted. Mean time to disconnection was 2.7 years (range 4 days-5.8 years). Computed tomography slices in the plane of the catheter helped visualize disconnections. Retrieval was difficult, and in 5 patients the disconnected catheter was not removable. Three catheters were completely within the ventricle. At presentation, 4 children suffered from severe neurological deficits, including one who died as a result of the shunt malfunction. CONCLUSIONS: BioGlide snap-design ventricular catheters are prone to disconnection. Continued vigilance and specific imaging are important. Catheter removal after disconnection may be difficult. Elective removal prior to disconnection in asymptomatic children has not been performed.
OBJECT: In late 2008, the authors recognized a new type of ventriculoperitoneal shunt failure specific to the Bio-Glide Snap Shunt ventricular catheters. This prompted a retrospective review of the patient cohort and resulted in a recall by the FDA in the US. METHODS: After the index cases were identified, the FDA was notified by the hospital, leading to a recall of the product. Hospital operative logs were used to identify patients in whom the affected products were used. A letter describing the risk was sent to all patients offering a free screening CT scan to look for disconnection. A call center was established to respond to patient questions, and an informational video was made available on the hospital website. The authors reviewed the records of the index cases and other cases subsequently identified. RESULTS: Seven index cases and an additional 16 cases of disconnection were identified in the 466 patients in whom a BioGlide Snap Shunt ventricular catheter had been implanted. Mean time to disconnection was 2.7 years (range 4 days-5.8 years). Computed tomography slices in the plane of the catheter helped visualize disconnections. Retrieval was difficult, and in 5 patients the disconnected catheter was not removable. Three catheters were completely within the ventricle. At presentation, 4 children suffered from severe neurological deficits, including one who died as a result of the shunt malfunction. CONCLUSIONS: BioGlide snap-design ventricular catheters are prone to disconnection. Continued vigilance and specific imaging are important. Catheter removal after disconnection may be difficult. Elective removal prior to disconnection in asymptomatic children has not been performed.
Authors: Rajiv R Iyer; Noah Gorelick; Karen Carroll; Ari M Blitz; Sarah Beck; Caroline M Garrett; Audrey Monroe; Betty Tyler; Sean T Zuckerman; Jeffrey R Capadona; Horst A von Recum; Mark G Luciano Journal: J Neurosurg Date: 2018-08-03 Impact factor: 5.115