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

Model Number	IBI-81683
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	09/11/2018
Type of Reportable Event	Serious Injury
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 effusion could not be conclusively determined.Per the ifu, cardiac perforation is a known risk during the use of this device.
Event or Problem Description
Related manufacturer reference: 3005334138-2018-00336, 3008452825-2018-00329.During an atrial fibrillation ablation procedure, a pericardial effusion occurred.Following the procedure, the patient became hypotensive.An echocardiogram confirmed a pericardial effusion, for which a pericardiocentesis was performed to stabilize the patient.The patient was followed in the icu.It was indicated the perforation occurred during ablation in the coronary sinus.There were no performance issues with any abbott device during the procedure.

• Brand Name: INQUIRY¿ OPTIMA¿DIAGNOSTIC CATHETER
• Common Device Name: ELECTRODE RECORDING CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 2375 morse ave; irvine CA 92614
• MDR Report Key: 7920410
• Report Number: 2030404-2018-00069
• Device Sequence Number: 16622945
• Product Code: DRF
• UDI-Device Identifier: 05414734305297
• UDI-Public: 05414734305297
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Report Date (Section B): 09/28/2018

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: 03/31/2021
• Device Model Number: IBI-81683
• Device Lot Number: 6402479
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2018
• Initial Report FDA Received Date: 09/28/2018
• 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: Other