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

Model Number	6250V-EH
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Perforation (2001); Pericardial Effusion (3271)
Date of Event	12/22/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during left ventricular (lv) lead implant, as the physician was attempted to enter the target lv vein, a perforation with pericardial effusion occurred.Contrast was used to identify the perforation.The placement was abandoned.An emergency echocardigram was obtained with a pericardial tap procedure.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• 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: 13225962
• Report Number: 9612164-2022-00154
• Device Sequence Number: 11790073
• Product Code: DQY
• UDI-Device Identifier: 00763000160289
• UDI-Public: 00763000160289
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 01/11/2022

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: 02/25/2023
• Device Model Number: 6250V-EH
• Device Catalogue Number: 6250V-EH
• Device Lot Number: 0010821406
• 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: 12/22/2021
• Initial Report FDA Received Date: 01/11/2022
• Date Device Manufactured: 08/27/2021
• 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: Required Intervention; Hospitalization; Life Threatening
• Patient Age: 74 YR
• Patient Sex: Female