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 Codes	Hemothorax (1896); Cardiac Perforation (2513)
Date of Event	05/08/2020
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 manufacturer reference: 2182269-2020-00050, 3008452825-2020-00256, 3008452825-2020-00257, 2182269-2020-00051.During ventricular tachycardia mapping in the left ventricle, a pericardial effusion occurred.After approximately an hour of mapping, using transseptal approach, the patient became hypotensive.An ultrasound confirmed a pericardial effusion for which a pericardiocentesis was administered.An additional ultrasound confirmed a hemothorax on the left side of the thorax, which was treated with a thorax drain.The cause and location of the pericardial effusion remains unknown, however it was noted the transseptal puncture was difficult.The patient was stable with minimal use of catecholamines and transferred to the icu.There were no performance issues with any abbott device.
Additional Manufacturer Narrative
Additional information: d10, g4, g7, h2, h3, h6, h10.One inquiry¿ steerable diagnostic catheter was received for investigation.The catheter shaft deflected when actuating the steering mechanism and deflected in the correct shape according to specifications and electrodes 1-10 met specifications of acceptable resistance values with no open or short circuits detected.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported pericardial effusion remains unknown.Per the ifu, cardiac perforation is a known risk during the use of this device.

• 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: 10098836
• Report Number: 3008452825-2020-00255
• Device Sequence Number: 3407504
• Product Code: DRF
• UDI-Device Identifier: 05414734303002
• UDI-Public: 05414734303002
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 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: 12/31/2022
• Device Model Number: IBI-81107
• Device Catalogue Number: IBI-81107
• Device Lot Number: 7350011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/08/2020
• Supplement Date Received by Manufacturer: 08/17/2020
• Initial Report FDA Received Date: 05/28/2020
• Supplement 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
• Concomitant Medical Products and Therapy/Usage Dates: AGILIS¿ NXT STEERABLE INTRODUCER; LIVEWIRE¿ ELECTROPHYSIOLOGY CATHETER DUO-DECAPOLAR; SUPREME¿ ELECTROPHYSIOLOGY CATHETER; TRANSSEPTAL NEEDLE, BRK SERIES
• Outcome Attributed to Adverse Event: Other