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

Model Number IBI-81250

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Air Embolism (1697); Heart Block (4444)

Event Date 07/11/2023

Event Type  Injury  

Event Description

Related manufacturing ref: 3005334138-2023-00338.During a pulmonary vein isolation procedure, air entered into the left atrium and stenosis of the coronary artery, atrioventricular block and decreased blood pressure occurred when the catheter straightener was inserted into the sheath requiring multiple interventions.This occurred when the hd grid catheter was removed after mapping the left atrium, and the optima insertion tool was inserted before placing the optima catheter.The air was identified in the left atrium when the insertion tool was inserted, and the sound of air was noted entering from the sheath.Immediately after that, the st level on the electrocardiogram increased and stenosis was confirmed by cag.An external pacemaker was then placed, coronary artery treatment and insertion of an intra-aortic balloon pump were performed, and the patient left the room.The intended procedure (pvi) could not be performed due to the occurrence of the event.The patient had brain surgery on friday, (b)(6) and was not stable following the procedure.

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 air embolism and heart block remains unknown.

Event Description

Additional information: the insertion tool was introduced into the valve of the swartz sheath in order to bring an inquiry optima catheter into the sheath and the la.During the time, when the insertion tool was opening the valve, negative pressure from deep irregular breathing sucked air into the sheath, which caused the complication.

• Brand Name: INQUIRY¿ OPTIMA¿ DIAGNOSTIC CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 2375 morse ave; irvine CA 92614
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 2375 morse ave; irvine CA 92614
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17450823
• MDR Text Key: 320311433
• Report Number: 2030404-2023-00052
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K042775
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/17/2023

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
• Device Operator: Health Professional
• Device Model Number: IBI-81250
• Device Lot Number: 8659395
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/11/2023
• Initial Date FDA Received: 08/03/2023
• Supplement Dates Manufacturer Received: 08/04/2023
• Supplement Dates FDA Received: 08/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SWARTZ¿ BRAIDED TRANSSEPTAL INTRODUCER.
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Sex: Male
• Patient Weight: 93 KG