MAUDE Adverse Event Report: CORDIS US CORP. AVANTI TRANSRADIAL; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Catalog Number	504615Z
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	01/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, a foreign object was found inside a 5f 11cm avanti+ sheath introducer.021" transradial kit prior to surgery.A new catheter sheath was used.There was no reportable patient injury.The foreign object involved was freely moveable.The packaging was noted to contain foreign material inside.The product was stored in the laboratory as required, and the actual product itself was not damaged.The hospital reported this case as an adverse event to the china nmpa.The device was returned for analysis.
Additional Manufacturer Narrative
The device was returned for evaluation; however, the engineering report is not yet available.Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
As reported, a foreign object was found inside a 5f 11cm avanti+ sheath introducer.021" transradial kit prior to surgery.A new catheter sheath was used.There was no reportable patient injury.The foreign object involved was freely moveable.The packaging was noted to contain foreign material inside.The product was stored in the laboratory as required, and the actual product itself was not damaged.The hospital reported this case as an adverse event to the china nmpa.The device was returned for analysis.A sterile si avanti+ transrad kit 11cm device was returned for investigation inside a sealed pouch bag.Unaided visual inspection of the received unit identified no abnormal conditions.A high-magnification evaluation was then performed to assess the previously identified area where foreign material had been reported.During this analysis, foreign material was identified within the sterile packaging, and no additional abnormal conditions were observed.The material was measured using a magnifying lens with a scale and was found to be within established specifications.Dimensional analysis was also performed to verify the size of the foreign material in accordance with final packaging inspection acceptance criteria.This evaluation confirmed that the observed material was within specification.The material was non-mobile, appeared adhered to the tray, and met the applicable acceptance criteria for non-mobile foreign material.In conclusion, foreign material was observed inside the sterile packaging of the received unit.Microscopic analysis confirmed that the material was non-mobile, adhered to the tray, and met established acceptance criteria.The observed condition is considered related to the manufacturing process due to the presence of foreign material within the sterile barrier however, it is within current specification limits.The reported ¿packaging/pouch/box ¿ foreign material in sterile package ¿ moveable particle¿ was not observed.However, the malfunctions ¿packaging/pouch/box ¿ foreign material in sterile package ¿ non moveable particle¿ was observed.The product is intended for use by trained healthcare professionals familiar with coronary diagnostic and interventional procedures.In this case, the condition was identified prior to use and the device was not used.A replacement device was selected, and there was no patient impact.The observed condition is considered related to the manufacturing process due to the presence of foreign material within the sterile barrier however, it is within current specification limits therefore, no further actions will be taken at this time.

• Brand Name: AVANTI TRANSRADIAL
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): CORDIS US CORP.; 14201 nw 60th avenue; miami lakes, florida 33014 2802
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 24547682
• Report Number: 9616099-2026-00360
• Device Sequence Number: 5662137
• Product Code: DRE
• UDI-Device Identifier: 10705032010276
• UDI-Public: (01)10705032010276(17)260930(10)18250424
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K970392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2026

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2026
• Device Catalogue Number: 504615Z
• Device Lot Number: 18250424
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2026
• 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: 02/11/2026
• Supplement Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2023
• 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: UNK.
• Patient Sex: Unknown