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, air bubbles formed immediately when a 100cm 1200psi angiographic catheter extension was connected to the device and operated, making it unusable.The same defect occurred in all five products.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 procedure was continued using a 1200 mm braid tubing line.All defective products were discarded and were not retained.
Additional Manufacturer Narrative
E1: (b)(6).As reported, air bubbles formed immediately when a 100cm 1200psi angiographic catheter extension was connected to the device and operated, making it unusable.The same defect occurred in all five products.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 procedure was continued using a 1200 mm braid tubing line.All defective products were discarded and were not retained.The devices associated with complaints (b)(4) were not returned for product analysis and were manufactured from lot 18582463.A product history review (phr) of lot 18582463 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 event cannot be determined based on the available complaint information.The complaint reported that the devices were not torqued against resistance during connection and that no difficulty was encountered while attempting to connect to a concomitant device.Review of the applicable angiographic catheter extensions eifu did not identify a specific warning or precaution addressing the reported leakage or formation of air bubbles during connection and operation.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 and its cause could not be established.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: 50725705
• Report Number: 9616099-2026-01248
• Device Sequence Number: 16099957
• Product Code: FPA
• UDI-Device Identifier: 10705032064729
• UDI-Public: (01)10705032064729(17)290430(10)18582463
• 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): 09/10/2026

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: 18582463
• 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: 09/11/2026
• 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