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	02/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation; however, the engineering report is not yet available.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, a 6f judkins left (jl) 3.5 infiniti diagnostic catheter broke into two parts when advanced over the guide wire.The catheter was removed, and a new diagnostic catheter from a non-cordis manufacturer was used to continue the procedure.There was no reported patient injury.The device was prepared on the sterile table, the internal lumen was purged, and it was attached to a teflon-coated diagnostic guide wire prior to advancement.The planned procedure was diagnostic coronary angiography.No problems occurred during preparation.The device was not used inside the patient, as the catheter broke before insertion.The product was stored, handled, and prepared according to the instructions for use (ifu) with no difficulty.No damage was observed before opening the package.There was no difficulty removing the device from the sterile packaging.He device was removed from the packaging by the connector.It was not torqued or steered by the hub but manipulated by the base of the catheter.The catheter broke while being advanced over a teflon guide wire toward the introducer.There was a little resistance during insertion.The device could not be advanced because the catheter broke.There was no difficulty removing the device.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 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: 24539039
• Report Number: 9616099-2026-00345
• Device Sequence Number: 18726452
• Product Code: DQO
• UDI-Device Identifier: 10705032014168
• UDI-Public: (01)10705032014168(17)280531(10)18461217
• 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): 05/04/2026

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: 534618T
• Device Lot Number: 18461217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2026
• 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: 02/09/2026
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2025
• 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 GUIDEWIRE.
• Patient Age: 71 YR
• Patient Sex: Female