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

Catalog Number	534645T
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2025
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, a new and unused 6f tl al i 100 cm infiniti diagnostic catheter was found with flakes inside the package, as if the plastic or coating had disintegrated.The procedure was completed using a new catheter that was sent in for replacement.There was no reported patient injury.There were damages found on the device prior to opening, but none on the device packaging.The issue was identified during pre-use inspection.The device was stored in a hybrid room in accordance with the instructions for use.The device will be returned for evaluation.
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 18187522 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, a new and unused 6f tl al i 100 cm infiniti diagnostic catheter was found with flakes inside the package, as if the plastic or coating had disintegrated.The procedure was completed using a new catheter that was sent in for replacement.There was no reported patient injury.There were damages found on the device prior to opening, but none on the device packaging.The issue was identified during pre-use inspection.The device was stored in a hybrid room in accordance with the instructions for use.The device was not received for evaluation.
Additional Manufacturer Narrative
Complaint conclusion: as reported, a new and unused 6f tl al i 100 cm infiniti diagnostic catheter was found with flakes inside the package, as if the plastic or coating had disintegrated.The procedure was completed using a new catheter that was sent in for replacement.There was no reported patient injury.There were damages found on the device prior to opening, but none on the device packaging.The issue was identified during pre-use inspection.The device was stored in a hybrid room in accordance with the instructions for use.The product was not returned for analysis.A review of the manufacturing documentation associated with lot 18187522 presented no issues during the manufacturing process that can be related to the reported event.Based on the limited information provided, it is not possible to draw a conclusion about a clinical relationship between the device and the event.Without the return of the device for analysis, the reported customer complaint ¿strain relief degradation¿ could not be evaluated.Without the return of the device the exact cause of the reported event could not be determined.Unspecified handling or storage factors may have contributed to the reported issue.Users should inspect for any signs of damage prior to and during use.Any product with damage should not be used.Based on the information available for review, there is no indication to suggest that the reported failure could be related to the design or manufacturing process of the unit.However, an investigation has been initiated to further investigate similar complications reported.

• 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: 22716054
• Report Number: 9616099-2025-01257
• Device Sequence Number: 18537532
• Product Code: DQO
• UDI-Device Identifier: 10705032014335
• UDI-Public: (01)10705032014335(17)260131(10)18187522
• 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): 09/08/2025

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: 01/31/2026
• Device Catalogue Number: 534645T
• Device Lot Number: 18187522
• 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: 07/09/2025
• Supplement Date Received by Manufacturer: 08/07/2025; 09/05/2025
• Initial Report FDA Received Date: 08/05/2025
• Supplement Report FDA Received Date: 09/02/2025; 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/21/2023
• 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