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).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.The angiographic catheter extensions associated with complaints (b)(4) were not returned for product analysis.The four devices were manufactured from lot 18582462.A product history review (phr) of lot 18582462 was completed, and the review does not suggest that the failure experienced by the customer was related to the manufacturing process.The reported ¿catheter extension tubing - leakage¿ could not be substantiated because the devices were not returned for product analysis.The exact cause of the leakage and difficulty disconnecting from the device cannot be determined.No evidence of use inconsistent with the product labeling or of a labeling-related contribution to the reported event was identified.Based on the available complaint information and manufacturing-history review, the reported leakage could not be substantiated, the exact cause of the leakage and difficulty disconnecting from the device remains undetermined, and the phr does not suggest that the failure experienced by the customer was related to the manufacturing process.Therefore, no further action will be taken at this time.

• 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: 50766299
• Report Number: 9616099-2026-01271
• Device Sequence Number: 15751823
• 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