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

Catalog Number	534550S
Medical Device Problem Codes	Crack (1135); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the user detected a defective hub on the 5f 110cm 6 side-hole (sh) infiniti diagnostic catheter.Two images of the luer hub were provided, which appear to show signs consistent with a potential crack and splintering.A red line is visible extending from the proximal portion of the hub toward the distal end, which may suggest that the hub was connected to a patient and that blood may have traveled through a crack in the component.There were no reports of patient injury.The device will be returned for evaluation.
Additional Manufacturer Narrative
This device is available for analysis but the engineering report is not yet available.Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
Complaint conclusion: as reported, there was cracking of the casing near the hub of a 6f infiniti pigtail 110cm 6sh diagnostic catheter.There was no reported patient injury.The device was never used.The cracking was noticed by scrub tech after opening package.An image was provided for review.The picture shows a catheter with a strain relief that shows signs of degradation.Per the account, there may have been a second pigtail with the same issue.No additional information related to this device was provided.Two photos were submitted for analysis, and they show a cracked luer hub.No additional anomalies or notable details were observed in the image.A non-sterile unit of catheter cath f5 inf pig 110 cm 6 sh was received coiled inside a clear plastic bag.The device was unpacked for evaluation.Visual inspection revealed no external damage or anomalies on the returned device components.Amplified imaging of the hub showed a splintered condition.Scanning electron microscope (sem) analysis identified fatigue striations and plastic deformation on the splintered area of the hub, consistent with tensile overload.These findings indicate the plastic material was subjected to a tensile force exceeding the hub component¿s yield strength prior to the observed damage.No manufacturing defects or material-related irregularities were detected, and no other anomalies were observed during the sem evaluation.The malfunction ¿luer hub ¿ splintered ¿ fragments can be injected¿ was observed during evaluation.The malfunction ¿luer hub ¿ cracked¿ was not seen during the evaluation.The exact cause of the event cannot be determined.Per the ifu, the device is intended for trained professionals; nothing in the available information indicates otherwise.Based on the event description and evaluation, the cause is undetermined, and handling factors cannot be excluded.The product evaluation did not provide 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 60 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: 22409247
• Report Number: 9616099-2025-01062
• Device Sequence Number: 8353819
• Product Code: DQO
• UDI-Device Identifier: 10705032013918
• UDI-Public: (01)10705032013918(17)270930(10)18374166
• 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,Followup
• Report Date (Section B): 10/31/2025

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: 534550S
• Device Lot Number: 18374166
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 06/09/2025
• Supplement Date Received by Manufacturer: 07/23/2025; 10/24/2025
• Initial Report FDA Received Date: 07/07/2025
• Supplement Report FDA Received Date: 08/18/2025; 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2024
• 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: UNKNOWN.
• Patient Sex: Unknown