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

Catalog Number 506610S

Device Problem Partial Blockage (1065)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/19/2023

Event Type  malfunction  

Event 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.

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.

• Brand Name: RAIN SHEATH TRANSRADIAL
• Type of Device: 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
• MDR Text Key: 333197578
• Report Number: 9616099-2024-00012
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10705032078948
• UDI-Public: 10705032078948
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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
• Date Manufacturer Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN.