MAUDE Adverse Event Report: CORDIS US CORP. RAILWAY; INTRODUCER, CATHETER

Catalog Number	RW5VBTB
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, a 5f railway sheathless access system vista brite tip bare wire broke off in the patient¿s body.An additional interventional radiology procedure was required, which involved snaring the device fragment out of the body via femoral approach.There was no additional reported patient injury.The access site vessel was not calcified but was described as severely tortuous.The device was flushed prior to use, and the vessel dilator was snapped into place at the hub.Difficulties during insertion were attributed to a small vessel with severe tortuosity.There were no difficulties withdrawing the device; however, upon withdrawal, a fragment was left behind after attempting to advance the system through severe tortuosity, and repeated torquing during insertion resulted in fracturing and shearing off the dilator.No damage was noted on the device or packaging prior to opening.The device was stored and prepared according to the instructions for use (ifu), the user was trained on the device, and the patient was reported to be stable and discharged.The device will not be returned for evaluation as all products from the procedure were discarded.
Additional Manufacturer Narrative
Health effect - impact code of 4614 - serious injury/ illness/ impairment and 4614 - serious injury/ illness/ impairment was added.
Additional Manufacturer Narrative
As reported, a 5f railway sheathless access system vista brite tip bare wire broke off in the patient¿s body.An additional interventional radiology procedure was required, which involved snaring the device fragment out of the body via femoral approach.There was no additional reported patient injury.The access site vessel was not calcified but was described as severely tortuous.The device was flushed prior to use.Difficulties during insertion were attributed to a small vessel with severe tortuosity.There were no difficulties withdrawing the device; however, upon withdrawal, a fragment was left behind after attempting to advance the system through severe tortuosity, and repeated torquing during insertion resulted in fracturing and shearing off the dilator.No damage was noted on the device or packaging prior to opening.The device was stored and prepared according to the instructions for use (ifu), the user was trained on the device, and the patient was reported to be stable and discharged.The device was not returned for evaluation as all products from the procedure were discarded.A product history record (phr) review of lot 18351683 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿vessel dilator ¿ separated¿ could not be substantiated because the device was not returned for evaluation and images were not provided.The exact cause of the event cannot be determined however, no damage was noted on the device or packaging prior to opening and, upon withdrawal, a fragment was left behind after attempting to advance the system through severe tortuosity, and repeated torquing during insertion resulted in fracturing and shearing off the dilator.Therefore, procedure and handling factors cannot be excluded.Users are trained to inspect for signs of damage prior to and during use.Any product with damage is not to be used.Information for safety is provided in the products labeling with the intent of making the user aware of the risks.According to the instructions for use (ifu), ¿if the device becomes kinked or increased resistance is felt upon insertion or advancement of the vessel dilator, investigate the cause before continuing.If the cause of the resistance cannot be determined and corrected, discontinue the procedure and withdraw the vessel dilator.¿ based on the available information and product analysis, there is no evidence to suggest the event is related to the device design or manufacturing process.Therefore, no preventative or corrective actions will be taken at this time.

• Brand Name: RAILWAY
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): CORDIS US CORP.; 14021 nw 60 avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 24175877
• Report Number: 9616099-2026-00146
• Device Sequence Number: 13256929
• Product Code: DYB
• UDI-Device Identifier: 10705032076869
• UDI-Public: (01)10705032076869(17)260731(10)18351683
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/01/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2026
• Device Catalogue Number: RW5VBTB
• Device Lot Number: 18351683
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2025
• Supplement Date Received by Manufacturer: 01/25/2026; 02/22/2026
• Initial Report FDA Received Date: 01/25/2026
• Supplement Report FDA Received Date: 01/26/2026; 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/05/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 73 KG