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

Model Number 11E84R1

Device Problem Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/22/2020

Event Type  malfunction  

Event 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
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MEDTRONIC, INC.; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 10337820
• MDR Text Key: 200824574
• Report Number: 10337820
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: 00763000359980
• UDI-Public: (01)00763000359980(17)230505(10)219975317
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 11E84R1
• Device Lot Number: 219975317
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/22/2020
• Event Location: Hospital
• Date Report to Manufacturer: 07/29/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 18980 DA
• Patient Weight: 107