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

Catalog Number	534676T
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the tip of a 6f 100 cm 3drc infiniti diagnostic catheter fractured while a.035-inch wire was being introduced through the catheter.The catheter did not become entrapped, and there was no device separation.A second 3drc infiniti catheter was used to complete the angiography procedure, and a contralateral approach was not used.There was no reported patient injury.There was no damage in the catheter packaging.The product was stored on the shelf in the cath.Lab and opened in sterile field.The device was prepped per the instructions for use (ifu).There was no kink in the distal of the catheter was remarked.The device damage was not noticed once the catheter was opened from the packaging.No force was applied because the catheter did not introduce through the sheath.At the target site, the vessel was non-calcified, mildly tortuous, non-bifurcating, and the stenosis percentage and presence of an acute angle were not available.At the access site, the vessel was neither calcified nor tortuous, and details on stenosis percentage, acute angle, and bifurcation were not available.The device was neither pulled from the packaging by the hub nor torqued/steered by the hub.No difficulties were encountered with insertion, advancement, withdrawal, or removal from sterile packaging.The patient was not hospitalized nor was hospitalization extended due to the event.Procedural cd information is not available.The device will not be returned.
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
As reported, the tip of a 6f 100 cm 3drc infiniti diagnostic catheter fractured while a.035-inch wire was being introduced through the catheter.The catheter did not become entrapped, and there was no device separation.A second 3drc infiniti catheter was used to complete the angiography procedure, and a contralateral approach was not used.There was no reported patient injury.There was no damage to the catheter packaging.The product was stored on the shelf in the cath.Lab and opened in sterile field.The device was prepped per the instructions for use (ifu).There was no kink in the distal of the catheter was remarked.The damage was not noticed once the catheter was opened from the packaging.No force was applied because the catheter did not introduce through the sheath.At the target site, the vessel was non-calcified, mildly tortuous, non-bifurcating, and the stenosis percentage and presence of an acute angle were not available.At the access site, the vessel was neither calcified nor tortuous, and details on stenosis percentage, acute angle, and bifurcation were not available.The device was neither pulled from the packaging by the hub nor torqued/steered by the hub.No difficulties were encountered with insertion, advancement, withdrawal, or removal from sterile packaging.The patient was not hospitalized nor was hospitalization extended due to the event.Procedural cd information is not available.The product was not returned for analysis.A product history record (phr) review of lot 18367079 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿catheter (body/shaft) ¿ cracked¿ and ¿catheter (body/shaft) ¿ impeded¿ could not be substantiated because the device was not returned and images were not reported.The exact cause of the event cannot be found however, handling factors cannot be excluded because the was not removed from the packaging by the hub as advised in the instructions for use.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), although not intended as a mitigation of risk, ¿to prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter.¿ based on the available information and product analysis, there is no evidence to suggest the event is related to the device design or manufacturing process.Therefore, no preventative or corrective actions will be taken at this time.

• Brand Name: INFINITI
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS US CORP; 14201 nw 60th avenue; miami lakes, florida 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: 23335438
• Report Number: 9616099-2025-01688
• Device Sequence Number: 13404859
• Product Code: DQO
• UDI-Device Identifier: 10705032014489
• UDI-Public: (01)10705032014489(17)270831(10)18367079
• 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): 11/24/2025

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 Catalogue Number: 534676T
• Device Lot Number: 18367079
• Was Device Available for Evaluation?: No
• 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: 09/28/2025
• Supplement Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 10/20/2025
• Supplement Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/11/2024
• 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
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 90 KG