MAUDE Adverse Event Report: CORDIS US CORP RAIN SHEATH TRANSRADIAL; INTRODUCER, CATHETER

Catalog Number	506610S
Medical Device Problem Codes	Material Frayed (1262); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available for analysis but has not yet been received.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, a 6f 10 cm rain sheath transradial hydrophilic thin-walled introducer sheath unraveled and could not be inserted.There was no reported patient injury.The exact event date and the lot number were not provided.One image was provided, and it shows what appears to be the distal end of the cannula of a catheter sheath introducer with a gray vessel dilator inserted through it.The distal tip of the cannula appears damaged; however, it cannot be determined if the tip is frayed, split, torn, or accordioned.The affected device has bloody residue on it, suggesting an attempt was made to insert the device inside a patient.The device is expected to be returned for evaluation.
Additional Manufacturer Narrative
As reported, a 6f 10cm rain sheath transradial hydrophilic thin-walled introducer sheath unraveled and could not be inserted.There was no reported patient injury.One image was provided, and it shows what appears to be the distal end of the cannula of a catheter sheath introducer with a gray vessel dilator inserted through it.The distal tip of the cannula appears damaged; however, it cannot be determined if the tip is frayed, split, torn, or accordioned.The affected device has bloody residue on it, suggesting an attempt was made to insert the device inside a patient.Multiple attempts to obtain supplemental information were made; however, additional event details were not provided.The device was not returned for evaluation as anticipated.A photo analysis performed by the quality engineering team for event-2025-18414 found that the attached image shows the distal end of a 5f sheath introducer with an accordion-like deformation at the distal tip; however, blood residue obscures the surface and prevents confirming the full extent or nature of the damage.No additional details could be identified from the image, and the photos do not provide sufficient information to assess whether any manufacturing-related issue is present.Based on the limited information available, no further conclusions can be drawn, and no actions will be taken at this time.The product was not returned for analysis.A product history record (phr) review could not be performed because the lot number was not provided.The reported ¿brite tip/distal tip ¿ frayed/split/torn¿ could not be substantiated because the device was not returned and the extent of the damages could not be determined during the photo analysis.Based on the photo analysis performed by the quality engineering team, the damages appear consistent with an accordioned condition.The exact cause of this condition cannot be determined, therefore procedural or 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), although not intended as a mitigation of risk, ¿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: RAIN SHEATH TRANSRADIAL
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): CORDIS US CORP; 14201 nw 60th avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 23324290
• Report Number: 9616099-2025-01679
• Device Sequence Number: 18603236
• Product Code: DYB
• UDI-Device Identifier: 10705032078948
• UDI-Public: 10705032078948
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2025

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 Catalogue Number: 506610S
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2025
• Supplement Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown