MAUDE Adverse Event Report: MEDTRONIC IRELAND ATTAIN COMMAND; CATHETER, PERCUTANEOUS

Model Number	6250V-MP
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	11/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during the implant procedure, a dissection occurred while the physician was using a steerable quadripolar catheter during coronary sinus cannulation. it was noted that the venous dissection was mild. the physician monitored the patient blood pressure, and the procedure was continued. no further patient complications have been reported as a result of this event.

• Brand Name: ATTAIN COMMAND
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 12832391
• Report Number: 9612164-2021-04463
• Device Sequence Number: 4364920
• Product Code: DQY
• UDI-Device Identifier: 00763000160326
• UDI-Public: 00763000160326
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K123153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/17/2022
• Device Model Number: 6250V-MP
• Device Catalogue Number: 6250V-MP
• Device Lot Number: 0010498357
• 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: 11/15/2021
• Initial Report FDA Received Date: 11/17/2021
• Date Device Manufactured: 12/17/2020
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 64 KG