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

Catalog Number	534560T
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available for analysis but has not yet been received.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, blue pieces and cracking of plastic near the hub were found on multiple diagnostic catheters, including 5f jl3.5 super torque plus diagnostic catheters (catalog number 534-518t), 5f jl4 super torque plus diagnostic catheters (catalog number 534-520t), 5f jl4.5 super torque plus diagnostic catheters (catalog number 534-517t), 5f im super torque plus diagnostic catheters (catalog number 534-560t), and a 5.2f mp a2(i) 100cm super torque plus diagnostic catheter (catalog number 533-556).The affected products were identified across multiple packages during stock inspection, and the packages had not been opened.There was no reported patient injury.The devices will be returned for evaluation.The devices will be returned for evaluation.Four images were reviewed and the show catheters inside their packaging.Polymer flakes can be seen inside the packaging, and they appear to have originated from the strain relief.
Additional Manufacturer Narrative
A product history record (phr) review of lot 18210599 revealed no anomalies or non-conformances during the manufacturing and inspection processes that could be associated with the event reported.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
The device was not returned for evaluation as anticipated.
Additional Manufacturer Narrative
As reported, blue pieces and cracking plastic near the hub were found on 27 diagnostic catheters, including super torque plus diagnostic catheters and infiniti catheters.The affected products were identified across multiple packages during stock inspection, and the packages had not been opened.There was no reported patient injury.Multiple attempts were made to obtain supplemental information; however, no additional event details were provided.The devices were not returned for evaluation as anticipated.Ten images related to all 9 affected lots were provided for review and evaluated under 27 separated complaints.2025-17852-22: ten photos were attached to event-2025-17852.One of the photos corresponds to the complaints associated with lot 18210599.The photo shows (b)(4) units, this pa (picture analysis) belongs to the unit marked as ¿unit 3¿ on the photo attached to the pa task.The graphic material shows the infiniti diagnostic catheter ref 534-560t that presented visual evidence of degradation on the strain relief.No other anomalies or notable details were observed in the images.A product history record (phr) review of lot 18210599 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿strain relief-degradation¿ was observed on 16 devices in the provided photos.It was not seen on the other 11 devices.Based on the available information, the specific cause of the degradation could not be determined.Potential contributing factors include storage conditions within the reporting facility or factors associated with the manufacturing process of the unit.Users are trained to inspect products for signs of damage prior to and during use, and any product showing damage is not to be used.The product labeling includes information for safety intended to make users aware of such risks.According to the instructions for use (ifu), ¿store in a cool, dark, dry place.Do not use if package is open or damaged.¿ while this guidance mitigates risks associated with storage, it does not eliminate the potential for degradation.Because a potential link to the manufacturing process could not be excluded, an investigation has been initiated to further evaluate potential contributing factors and implement further actions as appropriate.No additional 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, florida 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 23077615
• Report Number: 9616099-2025-01485
• Device Sequence Number: 15951683
• Product Code: DQO
• UDI-Device Identifier: 10705032013963
• UDI-Public: (01)10705032013963(17)260430(10)18210599
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/19/2025

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 Expiration Date: 04/30/2026
• Device Catalogue Number: 534560T
• Device Lot Number: 18210599
• Was Device Available for Evaluation?: No
• 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: 08/27/2025
• Supplement Date Received by Manufacturer: 10/23/2025; 11/05/2025
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 10/31/2025; 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/20/2023
• 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