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

Catalog Number	534642T
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	01/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, a fracture was found on a 6f 100cm multipurpose (mpa) 2 infiniti diagnostic catheter immediately upon opening the package after removal of the catheter from the sterile packaging during preparation.The fracture was located at the body near the tip and resulted in complete separation of the device.Another 6f 100cm mpa 2 infiniti diagnostic catheter was used to complete the procedure.There were no reported injuries to the patient.The device was stored according to the instructions for use (ifu).There was no damage to the packaging prior to use.The catheter was removed together with the cardboard holder.Prior to observing the fracture, the preparation step performed was shaping the tip.The device was not returned as expected.
Additional Manufacturer Narrative
Complaint conclusion: as reported, a fracture was found on a 6f 100cm multipurpose (mpa) 2 infiniti diagnostic catheter immediately upon opening the package after removal of the catheter from the sterile packaging during preparation.The fracture was located at the body near the tip and resulted in complete separation of the device.Another 6f 100cm mpa 2 infiniti diagnostic catheter was used to complete the procedure.There were no reported injuries to the patient.The device was stored according to the instructions for use (ifu).There was no damage to the packaging prior to use.The catheter was removed together with the cardboard holder.Prior to observing the fracture, the preparation step performed was shaping the tip.The device was not returned as expected.A product history record (phr) review of lot 18476979 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿brite tip/distal tip ¿ separated¿ could not be substantiated because the device was not returned and images were not provided.The exact cause of the event cannot be determined and use related factors (possible excessive force while shaping the tip) 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 products labeling with the intent of making the user aware of the risks.According to the instructions for use (ifu), to prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter.Based on the available information, there is no evidence to suggest the reported event is related to manufacturing or design issues.Therefore, no additional actions will be taken.

• Brand Name: INFINITI
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• 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 ; 7863138372
• MDR Report Key: 24690080
• Report Number: 9616099-2026-00405
• Device Sequence Number: 10041991
• Product Code: DQO
• UDI-Device Identifier: 10705032014304
• UDI-Public: (01)10705032014304(17)280630(10)18476979
• 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
• Type of Report: Initial
• Report Date (Section B): 03/25/2026

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: 534642T
• Device Lot Number: 18476979
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2026
• Initial Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/17/2025
• 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 100CM MPA 2 INFINITI DIAGNOSTIC CATHETER
• Patient Sex: Unknown