MAUDE Adverse Event Report: Medtronic Mexico S. De R.L. De CV MEDTRONIC AORTIC PUNCH; INSTRUMENTS, SURGICAL, CARDIOVASCULAR

Model Number	APU535
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/28/2026
Type of Reportable Event	Malfunction

• Brand Name: MEDTRONIC AORTIC PUNCH
• Common Device Name: INSTRUMENTS, SURGICAL, CARDIOVASCULAR
• Manufacturer (Section D): Medtronic Mexico S. De R.L. De CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer (Section G): Medtronic Mexico S. De R.L. De CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; +353(091)708096
• MDR Report Key: 50117230
• Report Number: 9617601-2026-04883
• Device Sequence Number: 10076765
• Product Code: DWS
• UDI-Device Identifier: 00763000122225
• UDI-Public: (01)00763000122225(17)280113(10)233023778
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/03/2026

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: APU535
• Device Catalogue Number: APU535
• Device Lot Number: 233023778
• 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: 07/30/2026
• Initial Report FDA Received Date: 08/03/2026
• Date Device Manufactured: 01/13/2026
• 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
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Sex: Male