MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. INQUIRY¿ AFOCUS II¿DIAGNOSTIC CATHETER; CATHETER, ELECTRODE RECORDING

Model Number	IBI-81680
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Perforation (2513); Vascular Dissection (3160)
Date of Event	10/08/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
During an atrial fibrillation ablation procedure a dissection occurred resulting in a cardiac tamponade.  while creating geometry, the user noted difficulty maneuvering the catheter due to the patient's anatomy in the left superior pulmonary vein (lspv) the patient became hypotensive.The ablation procedure was stopped and the patient was transferred to open heart surgery to repair the vessel dissection.Upon removal the catheter operated as expected and there were no performance issues with any abbott device.The patient is stable.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported dissection may have been procedural related.

• Brand Name: INQUIRY¿ AFOCUS II¿DIAGNOSTIC CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 2375 morse ave; irvine CA 92614
• MDR Report Key: 8016012
• Report Number: 2030404-2018-00075
• Device Sequence Number: 16489544
• Product Code: DRF
• UDI-Device Identifier: 05414734305273
• UDI-Public: 05414734305273
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K042775
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2018

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: 07/31/2020
• Device Model Number: IBI-81680
• Device Lot Number: 6116582
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/08/2018
• Supplement Date Received by Manufacturer: 10/27/2018
• Initial Report FDA Received Date: 10/29/2018
• Supplement Report FDA Received Date: 11/08/2018
• 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: Required Intervention
• Patient Age: 67 YR
• Patient Weight: 53