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
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.
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.The damage was identified after removal of the catheter from the sterile packaging during preparation.The fracture occurred at the body near the tip and resulted in a complete separation of the device.Another 6f 100cm mpa 2 infiniti diagnostic catheter was used to complete the procedure.No preparation steps were performed prior to observing the fracture.There were no reported injuries to the patient.The device will be returned for evaluation.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: b4, g3, g6, h1, h2, h3, h6, and h11.Complaint conclusion: as reported, a fracture was found on a 6f 100cm multipurpose (mpa) 2 infiniti diagnostic catheter immediately upon opening the package.The damage was identified after removal of the catheter from the sterile packaging during preparation.The fracture occurred at the body near the tip and resulted in a complete separation of the device.Another 6f 100cm mpa 2 infiniti diagnostic catheter was used to complete the procedure.No preparation steps were performed prior to observing the fracture.There were no reported injuries to the patient.A non-sterile cath f6inf tl mp a2 100cm 2sh device was returned for investigation.Visual inspection of the received unit during unaided eye inspection showed no abnormal conditions.A high-magnification microscopic evaluation of the brite tip/distal tip was also performed, and no abnormal conditions were observed.The unit did not present any damage or anomalies during visual inspection, and no abnormal conditions were identified during microscopic evaluation.Product analysis did not provide evidence suggesting the reported failure was related to manufacturing or design issues.The reported ¿brite tip/distal tip ¿ separated¿ was not substantiated because the returned device did not present with any damages.According to the device instructions for use, ¿to prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter.¿ based on the available information, the event was identified immediately upon opening the package; however, the specific handling during package removal was not described.Therefore, it cannot be determined whether the event aligned with or conflicted with that instruction.Visual and microscopic evaluation of the returned device did not identify damage or anomalies, and the product analysis did not identify evidence of a manufacturing or design issue.Accordingly, the exact cause of the event cannot be determined, and use-related factors cannot be excluded.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 ; 7863138372
• MDR Report Key: 24689385
• Report Number: 9616099-2026-00395
• Device Sequence Number: 18605547
• Product Code: DQO
• UDI-Device Identifier: 10705032014304
• UDI-Public: (01)10705032014304(17)280630(10)18476979
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2026

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2026
• 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: 02/28/2026
• Supplement Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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