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

Catalog Number	538420
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	10/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the proximal end of a 4f judkin¿s left (jl) 4.0 100 cm infiniti diagnostic catheter was found broken and could be plugged in and out repeatedly, suggesting it was not properly connected.There was no reported patient injury.The condition of the luer hub matched what was shown in the video.No damage was observed on the device or packaging before opening.The device was stored and prepared according to the instructions for use.No patient injury was reported in the additional information.The procedure was completed using another angiographic catheter.The user was trained in the use of the device.The device will be returned for evaluation.
Additional Manufacturer Narrative
This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
As reported, the proximal end of a 4f judkin¿s left (jl) 4.0 100 cm infiniti diagnostic catheter was found broken and could be plugged in and out repeatedly, suggesting it was not properly connected.There was no reported patient injury.The condition of the luer hub matched what was shown in the video.No damage was observed on the device or packaging before opening.The device was stored and prepared according to the instructions for use.No patient injury was reported.The procedure was completed using another angiographic catheter.The user was trained in the use of the device.The device will be returned for evaluation.One video was received for review, and it shows a catheter with a body/shaft separation that occurred under the strain relief.The non-sterile cath f4 inf jl 4 100 cm catheter was received coiled inside a clear plastic bag and unpacked for product evaluation.Visual inspection identified a separation of the catheter body/shaft at the strain relief area, approximately 101.2 cm from the distal tip, with no other damage or anomalies observed on the remaining device components.Dimensional analysis was performed near the damaged area to verify catheter inner and outer diameters, and all measurements were found to be within specification.Amplified imaging of the separated region demonstrated elongation of the plastic material, a characteristic typically associated with the application of excessive tensile stress, indicating that the component was subjected to a tensile load exceeding its yield strength prior to failure.No evidence of manufacturing defects or assembly-related issues was identified based on the information reviewed, and no corrective or preventive actions are warranted at this time.The reported ¿catheter body/shaft ¿ separated¿ was seen during the product evaluation.The root cause cannot be determined however, amplified images of the separated area showed signs that the component was subjected to a tensile load exceeding its yield strength prior to failure.Therefore, handling and procedurally related factors cannot be excluded.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 product labeling with the intent of making the user aware of the risks.According to the instructions for use (ifu), ¿treat all 4f (1.35 mm) catheters and smaller french sizes with ultimate care.The performance of these products may be impaired if not properly and cautiously handled during unpacking and preparation.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.; 14021 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: 23627925
• Report Number: 9616099-2025-01887
• Device Sequence Number: 13095549
• Product Code: DQO
• UDI-Device Identifier: 10705032014601
• UDI-Public: (01)10705032014601(17)280430(10)18447943
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K862244
• 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): 01/08/2026

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: 538420
• Device Lot Number: 18447943
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2025
• 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: 10/30/2025
• Supplement Date Received by Manufacturer: 12/30/2025
• Initial Report FDA Received Date: 11/23/2025
• Supplement Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2025
• 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: Female
• Patient Weight: 76 KG