MAUDE Adverse Event Report: MEDTRONIC, INC.; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number	11E84R1
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/22/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly male with history of hypertension.Procedure this day for coronary artery bypass graft; prior to using product, the antegrade cannula was observed to be misshaped and not used.A new set was opened and used for the procedure.No known harm to patient.

• Brand Name: NA
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MEDTRONIC, INC.; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 10337820
• Report Number: 10337820
• Device Sequence Number: 3854016
• Product Code: DWF
• UDI-Device Identifier: 00763000359980
• UDI-Public: (01)00763000359980(17)230505(10)219975317
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/22/2020
• Report Date (Section F): 07/22/2020

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: 11E84R1
• Device Lot Number: 219975317
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/29/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 107
• Date Report Sent to FDA: 07/22/2020