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

Catalog Number	534642T
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Related report numbers: 9616099202600025 / 9616099202600026 / 9616099202600027 / 9616099202600028 / 9616099202600029 / 9616099202600030 / 9616099202600031 / 9616099202600032 / 9616099202600033 / 9616099202600034 / 9616099202600036 / 9616099202600038 / 9616099202600040 / 9616099202600041 / 9616099202600042 / 9616099202600043 / 9616099202600044 / 9616099202600045 / 9616099202600046 / 9616099202600048 / 9616099202600058 / 9616099202600059 / 9616099202600060 / 9616099202600061 / 9616099202600062 / 9616099202600063 / 9616099202600064 / 9616099202600065 / 9616099202600066 / 9616099202600067 / 9616099202600068 / 9616099202600069 / 9616099202600070 / 9616099202600071 / 9616099202600072 / 9616099202600073/ 9616099202600074 / 9616099202600075 / 9616099202600082 / 9616099202600083.As reported, forty-five 6f mp a2 infiniti catheters were found to be broken immediately upon opening the package.When unpacking, it was found that the head end and the tube body had been spited.All 45 catheters were confirmed to have had the same malfunction.There was no reported injury to the patient.There was no damage to the packaging.The devices were removed by tearing the inner package and removing the catheter and cardboard together.The devices will not be returned for evaluation.One photo was submitted for analysis, and it shows a blue catheter with a separation of the body/shaft.No specific characteristics of the damage could be observed, and no additional details were visible in the image provided.The photos do not provide sufficient information to determine whether the observed separation is related to a design or manufacturing issue.A product history record (phr) review for the single device associated with the submitted image (lot: 18459089) revealed no anomalies or non-conformance's during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿brite tip/distal tip separated¿ was not observed in the provided image; however, the malfunction ¿catheter (body/shaft) ¿ separated¿ was observed on the device depicted.These findings cannot be substantiated for the remaining 44 devices, as they were not returned and no additional images were provided, and the exact cause of the reported events cannot be determined.In the absence of a confirmed failure mechanism or observable use-related factors, a definitive assessment of device labeling applicability or adequacy could not be meaningfully performed for this event.Based on the information available, including the reported event details, image review, and the product history record review for the single device associated with the submitted image, there is no evidence to suggest the reported separations are related to the device design or manufacturing process; therefore, no additional actions will be taken at this time.
Event or Problem Description
As reported, forty-five 6f mp a2 infiniti catheters were found to be broken immediately upon opening the package.When unpacking, it was found that the head end and the tube body had been spited.All 45 catheters were confirmed to have the same malfunction.There was no reported injury to the patient.There was no damage to the packaging.The devices were removed by tearing the inner package, and removing the catheter and cardboard together.The devices will not be returned for evaluation.

• Brand Name: INFINITI
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• 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 32574 ; MX 32574 ; 7863138372
• MDR Report Key: 24049964
• Report Number: 9616099-2026-00084
• Device Sequence Number: 18605800
• Product Code: DQO
• UDI-Device Identifier: 10705032014304
• UDI-Public: 10705032014304
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K970854
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/12/2026

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 Catalogue Number: 534642T
• 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: 12/15/2025
• Initial Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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