MAUDE Adverse Event Report: MEDTRONIC, INC. ATTAIN; CATHETER, FLOW DIRECTED

Model Number	6215
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Balloon on catheter would not passively deflate while being tested prior to inserting into body.The catheter was replaced with another and there were no further issues.

• Brand Name: ATTAIN
• Common Device Name: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 19700124
• Report Number: 19700124
• Device Sequence Number: 7991476
• Product Code: DYG
• UDI-Device Identifier: 00763000227982
• UDI-Public: (01)00763000227982(17)260124(10)24A24844
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/12/2024
• Report Date (Section F): 06/12/2024

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
• Device Model Number: 6215
• Device Lot Number: 24A24844
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 07/09/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/09/2024
• 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: 06/12/2024