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

Model Number	6248V-130L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Perforation of Vessels (2135); Pericardial Effusion (3271)
Date of Event	07/31/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the implant procedure of the left ventricular (lv) lead, the patient experienced a perforation.It was noted during the procedure, the coronary sinus was located and a sheath was advanced into the coronary sinus and a balloon venography located the target vessel.The lateral target vessel was cannulated with a subselecting catheter and then a second subselecting catheter was advanced into the target but a venography revealed the distal perforation.All the leads and sheaths were removed.A pericardial tap was performed and drained.The pocket was closed and the patient remained hemodynamically unstable.A second pericardial tap was performed at a difference angulation.Additional drainage occurred and ultimately the drainage stopped with a small residual effusion and the patient remained stable.No further patient complications have been reported as a result of this event.

• Brand Name: ATTAIN SELECT II
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 6937131
• Report Number: 9612164-2017-01442
• Device Sequence Number: 1354686
• Product Code: DQY
• UDI-Device Identifier: 00643169143173
• UDI-Public: 00643169143173
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 07/31/2017

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: 04/05/2019
• Device Model Number: 6248V-130L
• Device Catalogue Number: 6248V-130L
• Device Lot Number: 0008571788
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2017
• Initial Report FDA Received Date: 10/10/2017
• 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: 85 YR