MAUDE Adverse Event Report: CORDIS US CORPORATION INFINITI; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	N/A
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to system limitations, section h6 required to input type of investigation, investigation findings, and investigation conclusions for an initial report.Pending additional information to complete investigation.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, box of 6f inifinti pigtail 145 angle 110cm diagnostic catheters were damaged when they were delivered.The sterility of the devices were compromised.There was no reported patient injury.The boxes were damaged.The damage was noted upon the initial receipt of the product.The devices were not used.Other procedural details were requested but were not provided.The devices will not be returned for analysis.
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, box of 6f inifinti pigtail 145 angle 110cm diagnostic catheters were damaged when they were delivered.The sterility of the devices were compromised.There was no reported patient injury.The boxes were damaged.The damage was noted upon the initial receipt of the product.The devices were not used.Other procedural details were requested but were not provided.The product was not returned for analysis.A review of the manufacturing documentation associated with lot 18434706 presented no issues during the manufacturing process that can be related to the reported event.Based on the limited information provided, it is not possible to draw a conclusion about a clinical relationship between the device and the event.Without the return of the device for analysis, the reported customer complaint " catheter (body/shaft) damaged and packaging/pouch/box compromised sterility" could not be evaluated.The cause of the reported issue could not be determined.It is possible that shipping/storage/handling issues led to the reported event.Users should inspect for any signs of damage prior to and during use.Any product with damage should not be used.All devices should be handled with care and stored as per the instructions for use (ifu).Based on the information available for review, 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.

• Brand Name: INFINITI
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS US CORPORATION; 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: 22085265
• Report Number: 9616099-2025-00875
• Device Sequence Number: 7866944
• Product Code: DQO
• UDI-Device Identifier: 10705032014403
• UDI-Public: (01)10705032014403(17)280229(10)18434706
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K970854
• 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
• Report Date (Section B): 06/20/2025

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 Model Number: N/A
• Device Catalogue Number: 534652S
• Device Lot Number: 18434706
• 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: 04/29/2025
• Supplement Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 05/26/2025
• Supplement Report FDA Received Date: 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/29/2025
• 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