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

Model Number	IBI-81945
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	02/05/2019
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 may have been procedure related.Per the ifu, cardiac perforation an inherent risk of any electrode placement. .
Event or Problem Description
During a right atrial flutter procedure, a pericardial effusion occurred.When attempting to place the coronary sinus catheter, the device would cannulate the middle cardiac vein and would continually lose contact.The device was replaced to a non-abbott coronary sinus catheter, which also had difficulty being placed.After nearly 40 minutes of manipulation, the non-abbott catheter was able to be placed in the coronary sinus.The procedure was continued and bidirectional block was successfully achieved.When manipulating the ice catheter, a pericardial effusion was noted.A pericardiocentesis was performed to stabilize the patient.The user believed the perforation was due to the coronary sinus catheters.

• 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: 8377908
• Report Number: 3008452825-2019-00088
• Device Sequence Number: 430039
• Product Code: DRF
• UDI-Device Identifier: 05414734306348
• UDI-Public: 05414734306348
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 02/28/2019

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: 08/31/2021
• Device Model Number: IBI-81945
• Device Catalogue Number: IBI-81945
• Device Lot Number: 6629200
• 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: 02/05/2019
• Initial Report FDA Received Date: 02/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BIOSENSE WEBSTER CS CATHETER
• Outcome Attributed to Adverse Event: Required Intervention