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

Model Number	IBI-81104
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	09/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Related manufacturing reference: 3005334138-2024-00381.During the atrial fibrillation procedure, a pericardial effusion occurred which required a pericardiocentesis to stabilize the patient.After the transseptal puncture with the swartz braided sl0 introducer, the device was exchanged for an agilis 13 fr introducer to pre-map with an advisor hd grid catheter.The agilis was left side.A pericardial effusion was seen on ice.The procedure was stopped and a pericardiocentesis was performed to stabilize the patient, blood was drained from the right atrium.The physician states the effusion likely occurred while repositioning the coronary sinus catheter or while moving the swartz braided sl0 introducer.There were no reported performance issues with any abbott device.
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, cardiac tamponade and pericardial effusion are known risks during the use of this device.

• Brand Name: INQUIRY¿ STEERABLE 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
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 2375 morse ave; irvine CA 92614
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 20229257
• Report Number: 2030404-2024-00059
• Device Sequence Number: 3393688
• Product Code: DRF
• UDI-Device Identifier: 05414734302975
• UDI-Public: (01)05414734302975(10)10360614(17)270531
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2024

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 Model Number: IBI-81104
• Device Catalogue Number: IBI-81104
• Device Lot Number: 10360614
• 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: 09/10/2024
• Supplement Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 09/16/2024
• Supplement Report FDA Received Date: 10/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/03/2024
• 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: Required Intervention; Life Threatening
• Patient Sex: Unknown