MAUDE Adverse Event Report: Cordis US Corp. CATHETER EXTENSION; Set, Administration, Intravascular

Catalog Number	502102D
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, water leakage and air bubbles occurred immediately when a 100cm 1200psi angiographic catheter extension was connected to the device and operated, making the product unusable.The product was also difficult to disconnect from the device.There was no reported patient injury.The device was not torqued against resistance while connecting to the tubing, and no difficulty was encountered while attempting to connect to a concomitant device.The device is not being returned because the hospital discarded the product.
Additional Manufacturer Narrative
E1: (b)(6).Additional information is pending and will be submitted within 30 days upon receipt.

• Brand Name: CATHETER EXTENSION
• Common Device Name: Set, Administration, Intravascular
• Manufacturer (Section D): Cordis US Corp.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): Cordis US Corp.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua 32574 ; MX 32574 ; +011(786)3138372
• MDR Report Key: 50766266
• Report Number: 9616099-2026-01267
• Device Sequence Number: 9241422
• Product Code: FPA
• UDI-Device Identifier: 10705032064729
• UDI-Public: (01)10705032064729(17)290430(10)18582462
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K812231
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/14/2026

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
• Device Catalogue Number: 502102D
• Device Lot Number: 18582462
• 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: 08/19/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/12/2026
• 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 Sex: Unknown