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

Model Number	IBI-81107
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	02/19/2021
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 manufacturer report numbers: 3005334138-2021-00198, 3008452825-2021-00172, 3008452825-2021-00170, 3005334138-2021-00197, 2184149-2021-00099.Several hours following a pulmonary vein isolation (pvi) ablation procedure, a pericardial effusion was noticed.Following the procedure, while using the ensite x in voxel mode a pericardial effusion was detected.During the procedure, the patient was in stable condition and the pvi was completed with no adverse patient consequences.Several hours after the procedure, the patient became hypotensive, and an echocardiogram revealed a pericardial effusion.A pericardiocentesis was performed to stabilize the patient.The cause and location of the effusion remains unknown.Per the physician, the reported oversized shell involving the ensite x may have contributed to the effusion.The patient is currently in stable condition and has been discharged.

• 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
• MDR Report Key: 11585611
• Report Number: 3008452825-2021-00171
• Device Sequence Number: 19879454
• Product Code: DRF
• UDI-Device Identifier: 05414734303002
• UDI-Public: 05414734303002
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/29/2021

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: 10/31/2023
• Device Model Number: IBI-81107
• Device Catalogue Number: IBI-81107
• Device Lot Number: 7737416
• 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: 03/15/2021
• Initial Report FDA Received Date: 03/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention