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

Catalog Number	506610S
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the dilator of a 6f 10cm rain trans radial catheter sheath introducer (csi) could not be flushed due to an obstruction within the dilator.An image of the 6f rain csi dilator was provided.In the image, an unknown guidewire can be seen exiting the distal tip of the 6f rain csi dilator.An unknown substance can be seen at the tip of the guidewire as it exited the distal tip of the 6f rain csi dilator.There were no reported injuries to the patient.The device was never used inside of the patient.The device will not be returned for evaluation.
Additional Manufacturer Narrative
Please note the provided phone number for the initial reporter is (b)(6).Due to system limitations, the phone number could not be entered under section e.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the dilator of a 6f 10cm rain trans radial catheter sheath introducer (csi) could not be flushed due to an obstruction within the dilator.There were no reported injuries to the patient.The device was never used inside of the patient.The device was stored and prepped per instructions for use (ifu) and there was no damage to the device packaging prior to use.The dilator which came packaged with the 6f rain csi kit was used.
Additional Manufacturer Narrative
Complaint conclusion: as reported, the dilator of a 6f 10cm rain trans radial catheter sheath introducer (csi) could not be flushed due to an obstruction within the dilator.There were no reported injuries to the patient.The device was never used inside of the patient.The device was stored and prepped per instructions for use (ifu) and there was no damage to the device packaging prior to use.The dilator which came packaged with the 6f rain csi kit was used.No product was received for analysis, instead one picture related to the reported failures were attached to the complaint.An unknown substance can be seen at the tip of the guidewire as it exited the distal tip of the 6f rain csi dilator, which may have contributed to the reported incident.No other anomalies of the product can be noticed on the attached pictures.The failure reported by the customer as vessel dilator- obstructed- particles/material can be injected was confirmed as part of the picture analysis.However, the root cause of the failure experienced by the customer could not be conclusively determined during analysis of the picture.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, ¿inspect the system contents for any signs of damage; do not use if any damage is present.Prior to use, remove air from csi through the side port extensions by inverting and flushing with heparinized saline or suitable isotonic solution.¿ 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: RAIN SHEATH TRANSRADIAL
• 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: 18499102
• Report Number: 9616099-2024-00012
• Device Sequence Number: 20844353
• Product Code: DYB
• UDI-Device Identifier: 10705032078948
• UDI-Public: (01)10705032078948(17)260831(10)18238105
• 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,Followup
• Report Date (Section B): 08/15/2024

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
• Device Expiration Date: 08/31/2026
• Device Catalogue Number: 506610S
• Device Lot Number: 18238105
• Was Device Available for Evaluation?: No
• 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: 12/19/2023
• Supplement Date Received by Manufacturer: 01/12/2024; 08/15/2024
• Initial Report FDA Received Date: 01/11/2024
• Supplement Report FDA Received Date: 01/29/2024; 08/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2023
• 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