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

Model Number	IBI-81105
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	12/03/2018
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 remains unknown.Per the ifu, vascular perforation is an inherent risk of any electrode placement.
Event or Problem Description
Related manufacturing ref: 3005334138-2018-00505.During a right pulmonary vein contraction procedure a pericardial effusion occurred.Following ablation in the right atrium, after the patient was transferred to the recovery room, echography was performed.An effusion was observed and when checked again had not improved.A pericardiocentesis was performed to stabilize the patient.There were no performance issues with any abbott device.

• Brand Name: INQUIRY¿ STEERABLE DIAGNOSTIC CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA; 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: 8180966
• Report Number: 3008452825-2018-00432
• Device Sequence Number: 13727772
• Product Code: DRF
• UDI-Device Identifier: 05414734302982
• UDI-Public: 05414734302982
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K961924
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/19/2018

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-81105
• Device Catalogue Number: IBI-81105
• Device Lot Number: 6662955
• 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: 12/03/2018
• Initial Report FDA Received Date: 12/19/2018
• 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: TACTICATH¿ ABLATION CATHETER, SENSOR ENABLED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Weight: 49