MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC CARDINAL HEALTH; ANGIOGRAPHY/ANGIOPLASTY KIT

Model Number	SAN7HITEMI
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
From staff: when the tavr [transcatheter aortic valve replacement] team opened their sterile pack to set up the or room, it was discovered that the drape in pack was not sterile.It was covered in black dots.The team discarded the pack, saved the drape and label for reporting and starting their room opening over from the beginning.No unsterile equipment was used on the patient.This manager reported the incident to cardinal health and supply chain here at the hospital.Manufacturer response for angiography/angioplasty kit, cardinal health (per site reporter).Sales rep, [redacted] (see contact information below), will get a quality report filed and will issue a credit for the pack.Her response "i really apologize for this inconvenience and please keep me posted if you run into any more issues." [redacted].Sales representative- boston south.Acute operating room specialty products.Mobile: [redacted].

• Brand Name: CARDINAL HEALTH
• Common Device Name: ANGIOGRAPHY/ANGIOPLASTY KIT
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 22519165
• Report Number: 22519165
• Device Sequence Number: 18130515
• Product Code: OEQ
• UDI-Device Identifier: 10197106706541
• UDI-Public: (01)10197106706541
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/27/2025
• Report Date (Section F): 06/27/2025

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 Model Number: SAN7HITEMI
• Device Catalogue Number: SAN7HITEMI
• Device Lot Number: 546717
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 1 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/16/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/16/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 06/27/2025