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 Code	Vascular Dissection (3160)
Date of Event	08/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: product id: e110 icd, implanted: (b)(6) 2010 0184, product id: lead, implanted (b)(6) 2010.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during left ventricular (lv) lead implant the physician was able to place a guide wire, however, when the physician introduced the catheter, the catheter was unable to advance past the brachiocephalic vein and subclavian vein junction.The physician tried two other sheaths with the same result.The physician then injected contrast and it stayed in the mediastinum region and did not dissipate for a few minutes.It was noted there was an unconfirmed dissection of the brachiocephalic vein.The procedure was aborted and the patient was admitted for observation.A pin plug was placed into the left ventricular (lv) lead port of the device and the patient was referred to a cardiovascular surgeon for an lv epicardial lead placement in the future.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: 9087962
• Report Number: 9612164-2019-03984
• Device Sequence Number: 2333091
• 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): 09/19/2019

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: 12/22/2020
• Device Model Number: 6250V-EH
• Device Catalogue Number: 6250V-EH
• Device Lot Number: 0009799641
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2019
• Initial Report FDA Received Date: 09/19/2019
• 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: 81 YR