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

Model Number	N/A
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the puncture needle of a 5f avanti plus introducer sheath was found loose and detached inside the package.There was no reported patient injury.Multiple attempts to gather additional information have been made and have been unsuccessful.The device and 134 sterile devices were returned for evaluation.
Additional Manufacturer Narrative
Complaint conclusion: as reported, the puncture needle of a 5f avanti plus introducer sheath was found loose and detached inside the package.There was no reported patient injury.Multiple attempts to gather additional information have been made and have been unsuccessful.The device and 134 sterile devices were returned for evaluation.Twenty-nine product evaluations have been completed and have been investigated under complaints (b)(4) through (b)(4).All 29 devices presented with the same findings.They were all received within the sealed sterile packaging and during visual inspection, the needles were noted to be not secured to the plastic tray and were found outside of their plastic cover, leaving the tip exposed.No other signs of visible damage of anomalies were seen.The reported ¿packaging/pouch/box ¿ device not secure ¿ needle (exposed)¿ was found on 29 of the returned devices.As stated in the instructions for use, 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.The event was determined to be manufacturing related and within the scope of a previously initiated risk assessment, which remains the applicable risk assessment pathway for this event.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 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 ; 7863138372
• MDR Report Key: 25075707
• Report Number: 9616099-2026-00642
• Device Sequence Number: 10685767
• Product Code: DRE
• UDI-Device Identifier: 10705032010283
• UDI-Public: (01)10705032010283(17)270930(10)18376767
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/04/2026

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 Model Number: N/A
• Device Catalogue Number: 504616Z
• Device Lot Number: 18376767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2025
• 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: 04/08/2026
• Initial Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2024
• 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: CORDIS CONTRAST GUIDE
• Patient Sex: Unknown