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

Catalog Number	534518T
Medical Device Problem Code	Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2025
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, five (5) boxes of 5f judkins left 3.5 (jl3.5) infiniti diagnostic catheters and two (2) boxes of 5f multipurpose a mpa 2 sh (2 side holes) infiniti catheters were found to be damaged.No patient injuries were reported.The damage occurred during transport and affected multiple levels of packaging as well as the products themselves.Specifically, the shipping box and outer product boxes were damaged.The inner product pouches were also punctured from the outside, and the sterile pouches were received with punctures; however, the seals remained intact.The products were not stored in the lab and had not been brought into the lab prior to the discovery of the damage.The actual devices were also compromised, exhibiting kinks that render them unsuitable for use in procedures.An image was provided showing multiple outer boxes of diagnostic catheters inside a shipping container, several of which appear visibly deformed due to the damage.The affected devices will not be returned for evaluation.
Additional Manufacturer Narrative
As reported, five (5) boxes of 5f judkins left 3.5 (jl3.5) infiniti diagnostic catheters and two (2) boxes of 5f multipurpose a mpa 2 sh (2 side holes) infiniti catheters were found to be damaged.No patient injuries were reported.The damage occurred during transport and affected multiple levels of packaging as well as the products themselves.Specifically, the shipping box and outer product boxes were damaged.The inner product pouches were also punctured from the outside, and the sterile pouches were received with punctures; however, the seals remained intact.The products were not stored in the lab and had not been brought into the lab prior to the discovery of the damage.The actual devices were also compromised, showing kinks that make them unsuitable for use in procedures.The affected devices were not returned for evaluation.The complaint file for the affected devices included an attached pdf with photographic evidence.The first page shows an invoice format, and the second page displays a cardboard box container holding eight outer boxes of cordis product.Six of these outer boxes are identified as diagnostic catheter.All visible outer boxes show compressed and kinked conditions with varying severity.No other notable details were evident in the images.A product history record (phr) review both lots associated with this event (18456336 and 18450505) revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿packaging/pouch/box ¿ damaged-outer box¿ was seen during the product evaluation for all the affected devices.However, the reported ¿packaging/pouch/box ¿ damaged-inner package, catheter (body/shaft) ¿ kinked/bent and packaging/pouch/box ¿ compromised sterility¿ could not be substantiated for any of the affected devices because these damages were not seen in the images and the devices were not returned for evaluation.The exact cause of this event cannot be found, but storage and handling may be related factors.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, ¿store in a cool, dark, dry place.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 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: 22589328
• Report Number: 9616099-2025-01177
• Device Sequence Number: 15704611
• Product Code: DQO
• UDI-Device Identifier: 10705032013666
• UDI-Public: (01)10705032013666(17)280430(10)18456336
• 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): 08/22/2025

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: 534518T
• Device Lot Number: 18456336
• 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: 06/30/2025
• Supplement Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/28/2025
• 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
• Patient Sex: Unknown