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	03/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, when the vessel dilator of a 5f railway sheathless access system was removed from the packaging, it split in two.A new unknown railway device was used to complete the procedure.There was no reported patient injury.The box and packaging were intact.The device was inspected prior to use.There were no anomalies noted when it was removed from the package.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.The device will be returned for evaluation.
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: the picture analysis engineering report was completed, however, the final, approved draft of the engineering report and its conclusion is not yet available.However, it will be submitted within 30 days upon receipt.This device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: g3, g6, h1, h2, h3 and h6 as reported, when the vessel dilator of a 5f railway sheathless access system was removed from the packaging, it split in two.A new unknown railway device was used to complete the procedure.There was no reported patient injury.The box and packaging were intact.The device was inspected prior to use.There were no anomalies noted when it was removed from the package.Three pictures were submitted for analysis.In one of the pictures the packaging could be observed and the label information: catalogue rw5vbtb, lot number 18240131 and the name railway can be read.In the other two photos the vessel dilator is observed on the cardboard and a separated component is noted near the needle in the center.A non-sterile unit of catheter access kit, 5f, vbt, ss wire was subsequently received for analysis.Only the vessel dilator was returned for evaluation.During visual inspection, a separated condition was noted to the middle section of the vessel dilator.Inner diameter (id) and outer diameter (od) measurements were taken near the damages and were found within specification.Sem analysis was performed and presented evidence of elongations along the separated sections of the dilator.The reported ¿vessel dilator - separated¿ was confirmed since the vessel dilator was received separated at the middle section of the component.The elongations found on the material of the unit are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the vessel dilator was induced to a tensile force that exceeded the material yield strength prior to the separation.Handling factors may have contributed to the reported event.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 to make the user aware of the risks.According to the instructions for use (ifu), although not intended as a mitigation of risk, ¿store in a cool, dark, dry place.Do not use if package is open or damaged.Inspect the system contents for any signs of damage; do not use if any damage is present.¿ based on the available information, there is no indication that the event is related to the device design or manufacturing process.Therefore, no preventative or corrective actions will be taken at this time.
Additional Manufacturer Narrative
After further review, section d.4 primary unique device identification (udi) number has been corrected accordingly.

• Brand Name: RAILWAY
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): CORDIS US. CORP; 14201 nw 60 avenue; miami lakes FL 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: 18997100
• Report Number: 9616099-2024-00093
• Device Sequence Number: 8208502
• Product Code: DYB
• UDI-Device Identifier: 10705032076869
• UDI-Public: (01)10705032076869(17)250831(10)18240131
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2025
• Device Catalogue Number: RW5VBTB
• Device Lot Number: 18240131
• Was Device Available for Evaluation?: Yes
• 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: Not provided
• Supplement Date Received by Manufacturer: 04/05/2024; 06/03/2024; 08/21/2024
• Initial Report FDA Received Date: 03/28/2024
• Supplement Report FDA Received Date: 04/30/2024; 06/10/2024; 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN.
• Patient Sex: Unknown