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

Catalog Number	534621T
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2025
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, a 6f judkins right (jr4) 100 cm infiniti diagnostic catheter fractured during use in the patient.There was no reported patient injury.The device will not be returned.Another infiniti was used to complete the handling.The product was stored and handled according to the instructions for use, and no damage was noted prior to opening the package.There was no difficulty removing the device from the sterile packaging, and the device was prepped per the instructions for use (ifu) without any difficulties.The hospital reported this case as an adverse event to the china nmpa.
Additional Manufacturer Narrative
As reported, a 6f judkins right (jr4) 100 cm infiniti diagnostic catheter fractured during use in the patient.There was no reported patient injury.Another infiniti was used to complete the handling.The product was stored and handled according to the instructions for use, and no damage was noted prior to opening the package.There was no difficulty removing the device from the sterile packaging, and the device was prepped per the instructions for use (ifu) without any difficulties.The hospital reported this case as an adverse event to the china nmpa.The device was not returned for evaluation as anticipated.A product history record (phr) review of lot 18391304 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿catheter (body/shaft) cracked¿ could not be verified as the device was not returned for analysis.The exact cause cannot be determined.Without the return of the device for analysis and with the limited additional information provided, it is difficult to ascertain the root cause between the device and the event reported.According to the warnings in the safety information in the instructions for use, ¿this product is designed and intended for single use.It is not designed to undergo reprocessing and re-sterilization after initial use.Reuse of this product, including after reprocessing and/or re-sterilization, may cause a loss of structural integrity which could lead to a failure of the device to perform as intended and may lead to a loss of critical labeling/use information all of which present a potential risk to patient safety.Do not expose to organic solvents.Do not use with ethiodol¿ or lipiodol¿ contrast media, or other such contrast media which incorporates the components of these agents.Do not exceed maximum pressure rating printed on product label and hub.Failure to abide by the warnings in this labeling might result in damage to the device coating, which may necessitate intervention or result in serious adverse events.¿ neither the phr nor the information available suggest a design or manufacturing related cause for the reported event.Therefore, no corrective or preventive action 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 2802
• 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: 23898770
• Report Number: 9616099-2025-02069
• Device Sequence Number: 16045841
• Product Code: DQO
• UDI-Device Identifier: 10705032014199
• UDI-Public: (01)10705032014199(17)271031(10)18391304
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: 534621T
• Device Lot Number: 18391304
• 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: 12/03/2025
• Supplement Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 12/26/2025
• Supplement Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/19/2024
• 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