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

Model Number	N/A
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to system limitations, section h6 required to input type of investigation, investigation findings, and investigation conclusions for an initial report.Pending additional information to complete investigation.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, foreign material was observed during intra-procedural flushing of a 5f infiniti pigtail (pig) 110cm 6side holes (sh) diagnostic catheter after opening the product packaging.The device was replaced with new unknown angiographic catheter and the procedure was completed.There was no reported patient injury.The foreign material was not retained.The device will be returned for evaluation.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: g3, g6, h1, h2, h3 and h6.Complaint conclusion: as reported, foreign material was observed during intra-procedural flushing of a 5f infiniti pigtail (pig) 110cm 6side holes (sh) diagnostic catheter after opening the product packaging.The device was replaced with new unknown angiographic catheter and the procedure was completed.There was no reported patient injury.The foreign material was not retained.Additional information was requested but not provided.The non-sterile cath f5 inf pig 110cm 6sh device was returned for evaluation, where visual inspection identified a kinked/bent condition located at approximately 20 cm and 28 cm from the distal tip, with no additional anomalies or damage observed.Functional analysis was performed by flushing water through the proximal end using a laboratory syringe, which demonstrated unobstructed flow with no foreign material exiting the lumen.Dimensional analysis of the outer diameter near the kinked regions measured 0.0665 inches at both locations, which falls within the specified tolerance range, and inner diameter measurements were also within specification; measurements were obtained using calibrated micrometer and pin gauge equipment.Overall, the evaluation confirmed the presence of localized kinking without evidence of foreign material, lumen obstruction, or dimensional nonconformance, and there was no evidence to suggest the condition was related to manufacturing or design processes.The reported ¿catheter (body/shaft) ¿ foreign material¿ was not substantiated because no foreign material was observed, the foreign material was not returned and images were not provided; therefore, the exact source of the foreign material and point of origin cannot be determined.According to the instructions for use (ifu), ¿before use, flush all devices entering a blood vessel with sterile heparinized saline or a similar isotonic solution.¿ foreign material was reported during intra-procedural flushing; however, this observation was not confirmed during evaluation, and no material was available for analysis.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: 24339934
• Report Number: 9616099-2026-00261
• Device Sequence Number: 17346464
• Product Code: DQO
• UDI-Device Identifier: 10705032013918
• UDI-Public: (01)10705032013918(17)270531(10)18332038
• 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): 04/02/2026

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 Model Number: N/A
• Device Catalogue Number: 534550S
• Device Lot Number: 18332038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2026
• 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: 01/19/2026
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2024
• 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: DIAGNOSTIC GUIDEWIRE; UNKNOWN ANGIOGRAPHIC CATHETER,
• Patient Sex: Unknown