MAUDE Adverse Event Report: Cordis US. Corp INFINITI; Catheter, Percutaneous

Catalog Number	534621T
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	08/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, two 6f 100cm judkins right (jr) 4 vista brite tip guiding catheters had fractures of the body/shaft section.The damage was identified during preparation and there were no reported injuries to the patient.The devices were stored and prepared in accordance with the instructions for use (ifu).There was no damage to the device packaging and no difficulty removing the devices from the packaging.The facility does not use ultraviolet (uv) light or ozone for room sterilization.Additional details were requested but were not provided.The devices will be returned for evaluation.Addendum: both devices were returned with separations at the distal tip.
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.

• Brand Name: INFINITI
• Common Device Name: Catheter, Percutaneous
• 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 ; +011(786)3138372
• MDR Report Key: 50845561
• Report Number: 9616099-2026-01325
• Device Sequence Number: 21321390
• Product Code: DQY
• UDI-Device Identifier: 10705032014199
• 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
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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: 534621T
• Device Lot Number: 18455536
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/31/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2025
• 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: 6F angiographic catheter
• Patient Sex: Unknown