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

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	08/03/2020
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 pericardial effusion was not determined.Per the ifu, cardiac perforation is a known risk during the use of this device.
Event or Problem Description
Related manufacturer reference # 3008452825-2020-00386, 2030404-2020-00056.During a pulmonary vein isolation procedure, a pericardial effusion was noted.After placing the coronary sinus and right ventricle catheters, cardioversion was conducted.Following cardioversion, the blood pressure was noted to be lower in the sinus rhythm and fluids were given.The pericardial space was then assessed which revealed a pericardial effusion.The blood pressure then rose to an acceptable level and the procedure was completed.An effusion remained post echocardiogram, however the patient was deemed stable and no further action was taken.

• Brand Name: INQUIRY STEERABLE DIAGNOSTIC CATHETER
• Common Device Name: ELECTRODE RECORDING CATHETER
• 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: 10422208
• Report Number: 3008452825-2020-00388
• Device Sequence Number: 3094768
• Product Code: DRF
• UDI-Device Identifier: 05414734304146
• UDI-Public: 05414734304146
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K961924
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/18/2020

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: 01/31/2023
• Device Model Number: IBI-81404
• Device Catalogue Number: IBI-81404
• Device Lot Number: 7408805
• 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: 08/03/2020
• Initial Report FDA Received Date: 08/18/2020
• 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: Other
• Patient Weight: 131