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 and shaping the tip 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.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 and shaping the tip 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.There were no reported injuries to the patient.The device will be returned for evaluation.A sterile cath f6inf tl mp a2 100cm 2sh device involved in the reported complaint was returned for investigation inside a sealed pouch bag.Visual inspection showed four kinked/bent conditions on the catheter body/shaft located approximately at 21.0 cm, 22.0 cm, 58.0 cm, and 88.5 cm from the distal tip.These kinked/bent conditions were consistent with folds and constraint patterns from the original sterile packaging pouch.No cracks, separation, or other abnormalities were noted on the brite tip/distal tip, and no other anomalies were observed during the unaided visual inspection.Dimensional analysis was performed at the locations of the observed kinked/bent condition, and the results were within specification.Microscopic analysis of the brite tip/distal tip and the kinked/bent areas of the catheter body found no abnormal conditions on the brite tip/distal tip and confirmed the kinked/bent condition on the catheter body, consistent with the visual inspection findings.The returned unit therefore presented a kinked/bent condition on the catheter body at multiple locations consistent with folds from the packaging, while no abnormalities were observed on the brite tip/distal tip.The product analysis did not provide evidence to suggest that the failure is related to the manufacturing or design process.The reported ¿brite tip/distal tip ¿ separated¿ was not seen during the product evaluation.Several kinks that correspond with folds on the packaging were observed.The exact cause of the reported event cannot be determined.The instructions for use do not provide specific guidance regarding manual shaping or deformation of the catheter prior to insertion.The device is intended for use by trained healthcare professionals experienced in catheterization procedures, who are responsible for device handling and technique selection based on clinical judgment.Manual shaping is not defined as a device-specific instruction, requirement, or limitation within the ifu and is therefore considered an operator-dependent technique rather than a manufacturer-directed use condition.Based on the available information, there is no indication that this specific event is related to device design or the manufacturing process.Therefore, no further 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: 24689714
• Report Number: 9616099-2026-00400
• Device Sequence Number: 9770594
• 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): 04/14/2026

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: 03/30/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 04/14/2026
• 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