MAUDE Adverse Event Report: Cordis US Corp. AVANTI; Catheter, Percutaneous

Catalog Number	504605X
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during the product nationalization process of a 5f 11cm avanti plus catheter sheath introducer (csi), an unknown material was identified inside of the packaging, resembling a strand of hair.There were no reported patient injuries.The device will be returned for evaluation.
Additional Manufacturer Narrative
Please note that information regarding the facility where this event occurred is currently unknown.Additional information is pending and will be submitted within 30 days upon receipt.

• Brand Name: AVANTI
• Common Device Name: Catheter, Percutaneous
• 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: 50734363
• Report Number: 9616099-2026-01253
• Device Sequence Number: 10633094
• Product Code: DQY
• UDI-Device Identifier: 10705032009980
• UDI-Public: (01)10705032009980(17)290331(10)18577540
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K970392
• 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
• Type of Report: Initial
• Report Date (Section B): 09/11/2026

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: 504605X
• Device Lot Number: 18577540
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2026
• Initial Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/27/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: unknown.
• Patient Sex: Unknown