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

Catalog Number	534618T
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	06/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, a 6f 100 cm judkins left 3.5 (jl3.5) infiniti diagnostic catheter was found to be separated from the tip, resulting in the device being broken into two segments during an angiography procedure.A new catheter of the same curve was used to complete the angiography.There was no reported patient injury.The device had been stored, handled, and prepared in full accordance with the instructions for use (ifu).No device damage was seen prior to opening the packaging, and there was no difficulty removing the device from the sterile packaging or during preparation.The device involved was a ¿cath f6 inf tl jl 3.5 100 cm¿ catheter.The non-sterile unit was received coiled inside a transparent plastic bag and unpacked for evaluation.Visual inspection revealed two kinks on the body shaft approximately 24 and 49 cm from the distal end.The distal tip was separated approximately 90 cm from the proximal edge of the luer hub, and the separated segment (8 cm) was not returned for analysis.The separated edges showed evidence of elongations, fatigue lines, and plastic deformation consistent with twisted tension applied to the device.The braid wires also showed plastic deformation.These features are commonly associated with material damage due to tensile or twist overload, suggesting the material experienced forces exceeding its yield strength before the frayed condition occurred.Dimensional analysis was performed near the damage areas and confirmed that both outer and inner diameters were within specification.No other significant observations were noted.The reported ¿catheter (body/shaft)-kinked/bent¿ and ¿brite tip/distal tip-separated¿ were seen during the product evaluation.Product evaluation results presented evidence of material tensile overload suggesting the device was exposed to excessive force.Handling factors are a possible cause.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.To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter.¿ 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.
Event or Problem Description
As reported, a 6f 100 cm judkins left 3.5 (jl3.5) infiniti diagnostic catheter was found to be separated from the tip, resulting in the device being broken into two segments during an angiography procedure.A new catheter of the same curve was used to complete the angiography.There was no reported patient injury.The device had been stored, handled, and prepared in full accordance with the instructions for use (ifu).No device damage was observed prior to opening the packaging, and there was no difficulty removing the device from the sterile packaging or during preparation.The device was returned for evaluation.

• 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 32574 ; MX 32574 ; 7863138372
• MDR Report Key: 22777916
• Report Number: 9616099-2025-01299
• Device Sequence Number: 9185136
• Product Code: DQO
• UDI-Device Identifier: 10705032014168
• UDI-Public: (01)10705032014168(17)251231(10)18177751
• 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): 08/11/2025

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 Expiration Date: 12/31/2025
• Device Catalogue Number: 534618T
• Device Lot Number: 18177751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2025
• 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: 08/07/2025
• Initial Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2023
• 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 Age: 64 YR
• Patient Sex: Male
• Patient Weight: 70 KG