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

Model Number	IBI-81531
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Cardiac Perforation (2513); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
During a procedure, the patient became hypotensive and a tamponade was confirmed.
Additional Manufacturer Narrative
The product's lot number could not be obtained, therefore the primary di number is provided (d4), but full udi information is not available.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Review of the device history record was not possible as the lot number is unknown.Based on the information received, the cause of the reported cardiac tamponade could not be conclusively determined.Per the ifu, cardiac perforation is a known risk during the use of this device.The physician alleges that the perforation occurred during transseptal puncture, either where the septum was initially crossed, or during positioning of the non-abbott transseptal device with several attempts.
Event or Problem Description
During an atrial fibrillation procedure, after performing transseptal puncture with a non-abbott faradrive sheath and versacross rf wire, the patient became hypotensive, and a tamponade was confirmed.The ice catheter was positioned in the right atrium, and the coronary sinus catheter was placed in the coronary sinus.The transseptal devices were then advanced into the svc.The septum was crossed using rf from the vsx wire and it was not certain where the wire and sheath were advancing to.The stick may have been too anterior.The devices were pulled back to the right atrium for a different transseptal position, and after several attempts the patient's pressure began to drop.The tamponade was then seen on ice.A pericardiocentesis was performed, stabilizing the patient and the procedure was then stopped.There were no performance issues with any abbott devices.The physician alleges that the perforation occurred during transseptal puncture, either where the septum was initially crossed, or during positioning of the non-abbott transseptal device with several attempts.

• Brand Name: INQUIRY ¿ STEERABLE DIAGNOSTIC CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL; 2375 morse ave; irvine CA 92614
• Manufacturer (Section G): ST. JUDE MEDICAL; 2375 morse ave; irvine CA 92614
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 21511904
• Report Number: 2030404-2025-00010
• Device Sequence Number: 4707833
• Product Code: DRF
• UDI-Device Identifier: 05414734304788
• UDI-Public: 05414734304788
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 04/16/2025

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-81531
• Device Catalogue Number: IBI-81531
• 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: 02/06/2025
• Supplement Date Received by Manufacturer: 04/16/2025
• Initial Report FDA Received Date: 03/04/2025
• Supplement Report FDA Received Date: 04/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown