TightRail Rotating Dilator Sheath

Description of Event or Problem

A Philips employee became aware of a journal article (published online 06-MAR-2026), ¿Impact of patent foramen ovale on transvenous lead extraction characteristics and outcomes¿. The study retrospectively aimed to identify the prevalence of patent foramen ovale (PFO) in patients undergoing transvenous lead extraction (TLE) and compare the incidence of adverse events associated with TLE in patients with Cardiac Implantable Electronic Device (CIEDs). A total of 283 patients who underwent lead extraction procedures were enrolled in the study between June 2020 and October 2025. All extractions were performed with Spectranetics TightRail Rotating Dilator Sheaths and/or Spectranetics GlideLight Laser Sheaths.Complications included 1 patient who experienced a stroke 26 days post-procedure (MDR #3007284006-2026-00403, MDR #3007284006-2026-00404). Additionally, 1 death was caused by stroke-related complications (MDR #3007284006-2026-00405).Although generalized patient information/medical history was listed within the journal article, specific patient/case detail was not provided for the adverse events involving the Spectranetics devices. Additionally, the date of procedure was not listed for these events; therefore, 06MAR2026 has been used, the date of publication.Park A et al_2026_ Impact of patent foramen ovale on transvenous lead extraction characteristics and outcomes. https://creativecommons.org/licenses/by/4.0/a; https://doi.org/10.1016/j.hroo.2026.02.024; Impact of patent foramen ovale on transvenous lead extraction characteristics and outcomes - Heart Rhythm O2.This report captures the death that occurred after use of the TightRail device. There was no alleged malfunction of any Spectranetics devices in use during the procedure.

Additional Manufacturer Narrative

A2) Patient Age - mean age was 64.98 years ± 15.17.A3a) Patient Sex - 190 males, 99 females.A3b-A6) Specific patient/case detail was not provided.B4) Date listed is the date the manufacturer became aware.B6) Patient information regarding relevant tests/laboratory data - Specific patient/case detail was not provided.D4/H4) The lot number was not provided, thus the following information is unknown: Model/Catalog Number, Unique ID, Expiration Date, and Manufacture Date. E) Although the journal article originated from the United States, physician and facility information are unknown; therefore, the information listed is the Corresponding Author of the journal article.H3) The device was discarded, thus no product investigation was performed.H6) Per IFU, stroke and death are listed as potential adverse events with use of the TightRail device.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the National Competent Authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.