MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA 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	07/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
Related manufacturing ref: 3005334138-2019-00421, 3005334138-2019-00422, 3008452825-2019-00386, 3008452825-2019-00387.During a pulmonary vein isolation procedure, a pericardial effusion occurred.Following geometry collection and ablation of the right-sided upper pulmonary vein, the patient became hypotensive.An echocardiogram revealed an effusion.A tamponade was diagnosed and a pericardiocentesis was performed which stabilized the patient.There were no performance issues with any abbott devices.
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.

• 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: 8876570
• Report Number: 3008452825-2019-00385
• Device Sequence Number: 2537178
• Product Code: DRF
• UDI-Device Identifier: 05414734303002
• UDI-Public: 05414734303002
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Followup
• Report Date (Section B): 09/05/2019

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: 04/30/2022
• Device Model Number: IBI-81107
• Device Catalogue Number: IBI-81107
• Device Lot Number: 6991107
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/26/2019
• Supplement Date Received by Manufacturer: 08/09/2019
• Initial Report FDA Received Date: 08/08/2019
• Supplement Report FDA Received Date: 09/05/2019
• 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: ADVISOR HD GRID MAPPING CATHETER; INQUIRY STEERABLE DIAGNOSTIC CATHETER; SUPREME ELECTROPHYSIOLOGY CATHETER; TACTICATH CONTACT FORCE ABLATION CATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR