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

Catalog Number	534552S
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, there is a hair sealed in the package of a 5f 145-degree 110cm 6 side hole (sh) infiniti diagnostic catheter.There were no reports of patient injury.Two images were provided for review: one displays the product labeling of an infiniti diagnostic catheter, and the other shows the catheter body inside the pouch.A hair-like foreign body is visible within the package, but it is not possible to determine from the images alone whether the sterile barrier has been compromised.The device will be returned for evaluation.
Additional Manufacturer Narrative
Complaint conclusion: as reported, there is a hair sealed in the package of a 5f 145-degree 110cm 6 side hole (sh) infiniti diagnostic catheter.There was no reported patient injury.The hair was seen prior to the package being opened.One of the technicians had begun to open it to prevent it from being used but was stopped.The package was slightly open at the top.The box was not available, as the items are typically removed from the box immediately to be hung in the room.Two images were provided for review: one displays the product labeling of an infiniti diagnostic catheter, and the other shows the catheter body inside the pouch.A hair-like foreign body is visible within the package, but it is not possible to determine from the images alone whether the sterile barrier has been compromised.The device was not received for evaluation.Two images related to the reported failure were provided by the customer for event 2025-16169.The first shows the product labeling of the infiniti diagnostic catheter, and the second displays the catheter body inside its pouch.A hair is visible inside the packaging.Based on visual analysis of the images, the presence of the hair inside the packaging was confirmed; however, it could not be conclusively found whether it was present prior to the package being opened.A technician had begun to open the package to prevent its use but was interrupted, leaving uncertainty about the seal status at the time the hair was seen.The images do not provide sufficient evidence to verify whether the sterile barrier was fully intact when the hair was first noted.Due to these limitations, the root cause of the issue could not be definitively found.The complaint was reviewed with the process engineering team, and it was concluded that there is insufficient evidence to confirm whether the condition is related to the infiniti diagnostic catheter¿s manufacturing processes.The reported ¿packaging/pouch/box- foreign material in sterile package- moveable particle¿ could not be substantiated.The device was and packaging was not returned and it cannot be conclusively found if the package was fully sealed when the hair was first noticed.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, ¿do not use if package is open or damaged.¿ 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: INFINITI
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 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: 22495643
• Report Number: 9616099-2025-01110
• Device Sequence Number: 7087010
• Product Code: DQO
• UDI-Device Identifier: 10705032013925
• UDI-Public: (01)10705032013925(17)280229(10)18429511
• Combination Product (Y/N): N
• 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): 08/14/2025

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: 534552S
• Device Lot Number: 18429511
• 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: 06/16/2025
• Supplement Date Received by Manufacturer: 08/01/2025
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/14/2025
• 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