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

Model Number	IBI-81404
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	01/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
During a cryo atrial fibrillation procedure, an effusion occurred in the left atrium.The physician had cryo ablated the left veins and was moving the ibi quad into the svc for phrenic pacing to begin cryo ablation of the right veins when the anesthesia team noticed a drop in the patient¿s blood pressure.An ultrasound confirmed the pericardial effusion.The patient coded on the table and was rushed to emergency surgery and a pericardiocentesis was performed.The current patient status is unknown.There were no performance issues with any abbott devices.
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.Per the ifu, vascular perforation is an inherent risk of any electrode placement.
Event or Problem Description
Additional information received on 2/3/22 stated the patient passed away the night of the procedure.

• Brand Name: INQUIRY¿ STEERABLE DIAGNOSTIC CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer (Section G): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13391840
• Report Number: 3008452825-2022-00033
• Device Sequence Number: 17206571
• Product Code: DRF
• UDI-Device Identifier: 05414734304146
• UDI-Public: 05414734304146
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K961924
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2022

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: 09/30/2024
• Device Model Number: IBI-81404
• Device Catalogue Number: IBI-81404
• Device Lot Number: 8186455
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2022
• Supplement Date Received by Manufacturer: 01/20/2022
• Initial Report FDA Received Date: 01/31/2022
• Supplement Report FDA Received Date: 02/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Male