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

Model Number	IBI-81659
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	01/25/2021
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 incident could not be conclusively determined.
Event or Problem Description
Related mfr number: 3005334138-2021-00070.During an atrial fibrillation cryoablation procedure, the patient developed a pericardial effusion.The patient had unusual cardiac anatomy.Two different transseptal needles were used to make multiple attempts to cross the atrial septum.After what was believed to be a successful puncture, the introducer was advanced and the diagnostic catheter was inserted to collect geometry and local egms.It was difficult to collect geometry as it was not clear where the catheter was placed in the heart.Soon after the mapping catheter was placed, arterial hypotension was noted, and the procedure was aborted.Intracardiac echocardiography was used to locate the effusion.Cardiopulmonary resuscitation was performed along with administration of an epinephrine drip, followed by a pericardiocentesis to stabilize the patient.Following pericardiocentesis, the patient went into ventricular fibrillation and was cardioverted.Spontaneous circulation resumed, and the patient was noted to be in supraventricular tachycardia.The patient was transferred to the intensive care unit, and was stable and off ventilation on (b)(6) 2021.

• Brand Name: INQUIRY OPTIMA DIAGNOSTIC CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 2375 morse ave; irvine CA 92614
• MDR Report Key: 11312040
• Report Number: 2030404-2021-00006
• Device Sequence Number: 14137435
• Product Code: DRF
• UDI-Device Identifier: 05414734305150
• UDI-Public: 05414734305150
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K042775
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/10/2021

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: 07/31/2023
• Device Model Number: IBI-81659
• Device Catalogue Number: IBI-81659
• Device Lot Number: 7627436
• 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: 01/25/2021
• Initial Report FDA Received Date: 02/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SWARTZ GUIDING INTRODUCER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR