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	Cardiac Arrest (1762); Perforation (2001); Pericardial Effusion (3271)
Date of Event	05/12/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an upgrade procedure, the physician cannulated the coronary sinus ostium with the delivery catheter and guidewire and advanced the catheter into what was believed to be the coronary sinus branch.Contrast was injected and the contrast filled the pericardial cavity but there was no staining noted.The patient then became unresponsive and cardiopulmonary resuscitation (cpr) was performed for approximately 30 seconds and the patient then became responsive.Cpr was stopped and an echocardiogram was performed, which showed a five to ten percent effusion and a perforation of pericardium was noted.The delivery catheter was removed and the physician chose to implant a right ventricular (rv) lead and connect it to the device with a plugged lv port for a future implant to attempt an epicardial lv lead implant.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
• MDR Report Key: 6780402
• Report Number: 9612164-2017-01036
• Device Sequence Number: 11097494
• Product Code: DQY
• UDI-Device Identifier: 00643169142886
• UDI-Public: 00643169142886
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K123153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/12/2017

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: 02/13/2018
• Device Model Number: 6250V-EH
• Device Catalogue Number: 6250V-EH
• Device Lot Number: 0008156229
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2017
• Initial Report FDA Received Date: 08/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 82 YR