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

Catalog Number	534570T
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation; however, the engineering report is not yet available.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, four (4) 5f 100 cm infiniti right coronary bypass (rcb) diagnostic catheters deteriorated near the hub while still in the packaging.It is possible that uv light exposure occurred through the crack in the cabinet.The only catheters affected were those hanging on the middle rack, which was aligned with the cabinet opening.There was no reported patient injury.The catheters were stored in a cabinet with ultraviolet (uv) protection.There was no visible packaging damage.No photographs are available.The devices were returned for evaluation.
Additional Manufacturer Narrative
A product history record (phr) review of lot 18309800 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.
Additional Manufacturer Narrative
As reported, four (4) 5f 100 cm infiniti right coronary bypass (rcb) diagnostic catheters deteriorated near the hub while still in the packaging.It is possible that uv light exposure occurred through the crack in the cabinet.The only catheters affected were those hanging on the middle rack, which was aligned with the cabinet opening.There was no reported patient injury.The catheters were stored in a cabinet with ultraviolet (uv) protection.There was no visible packaging damage.All four devices were returned for evaluation and were evaluated under 2025-15807-1 through 2025-15807-4.They all originated from lot 18309800 and a product history record (phr) review revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.2025-15807-4: one, cath f5 inf rcb 100cm, was received inside its manufacturing pouch, which was properly sealed, and the sterility was not compromised.The catheter was found folded to fit inside the plastic bag, resulting in kinks that matched the folds.Inspection focused on the strain relief revealed a degradation condition and a yellowish discoloration on the hub, which is consistent with exposure to environmental factors such as ultraviolet radiation, thermal stress, or chemical agents.The reported ¿strain relief-degradation¿ was seen on all four devices and the exact cause of these events is unknown.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, ¿store in a cool, dark, dry place.Do not use if package is open or damaged.¿ based on the available information and product analysis, the cause of the strain relief degradation could not be found; however, it is potentially related to the manufacturing process of the unit.Therefore, an investigation has been started to further review the potential causes.No further action 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
• 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: 22301741
• Report Number: 9616099-2025-00999
• Device Sequence Number: 15610491
• Product Code: DQO
• UDI-Device Identifier: 10705032013994
• UDI-Public: (01)10705032013994(17)270331(10)18309800
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/15/2025

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: 534570T
• Device Lot Number: 18309800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2025
• 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: 05/29/2025
• Supplement Date Received by Manufacturer: 07/21/2025; 08/06/2025
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 07/22/2025; 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/20/2024
• 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