MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION MEDTRONIC AORTIC PUNCH; INSTRUMENTS, SURGICAL, CARDIOVASCULAR

Model Number	APU540
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received information that prior to use of these 6 aortic punches, it was reported that the packaging of the aortic punches had debonded from the plastic packaging, making the devices not sterile as they were open and no longer sealed.It was stated that the aortic punches were at the facility for about 20 days and only the outer box packaging was checked upon arrival at the facility.It was reported that the aortic punches were stored at room temperature with good ventilation and all 6 aortic punches in the box experienced the same de-bonding issue.The devices were not used.No patient involvement was reported.

• Brand Name: MEDTRONIC AORTIC PUNCH
• Common Device Name: INSTRUMENTS, SURGICAL, CARDIOVASCULAR
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 19674161
• Report Number: 2025587-2024-03793
• Device Sequence Number: 6587515
• Product Code: DWS
• UDI-Device Identifier: 00763000122232
• UDI-Public: 00763000122232
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K800122
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 07/04/2024

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: 09/18/2025
• Device Model Number: APU540
• Device Catalogue Number: APU540
• Device Lot Number: 227344531
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2024
• Initial Report FDA Received Date: 07/04/2024
• Date Device Manufactured: 09/18/2023
• 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
• Patient Sex: Unknown