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

Model Number	6250V-MPX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Vascular Dissection (3160); Pericardial Effusion (3271)
Date of Event	11/21/2017
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 the delivery catheter caused a coronary sinus dissection as well as infiltration of the epicardial fat with subsequent pericardial effusion.The patient was monitored with no change in hemodynamics.A chest x-ray the following day appeared normal and the patient was discharged.The patient is a participant in the attain stability quad clinical study.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: 7257947
• Report Number: 9612164-2018-00317
• Device Sequence Number: 141129
• Product Code: DQY
• UDI-Device Identifier: 00643169142848
• UDI-Public: 00643169142848
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 02/08/2018

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: 02/28/2018
• Device Model Number: 6250V-MPX
• Device Catalogue Number: 6250V-MPX
• Device Lot Number: 0008200045
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2017
• Initial Report FDA Received Date: 02/08/2018
• 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
• Patient Age: 69 YR
• Patient Weight: 108