MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. 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	07/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Event or Problem Description
Related manufacturing reference: 3005334138-2019-00527, 3005334138-2019-00528, 2030404-2019-00096, 2030404-2019-00097.Following an ablation procedure a pericardial effusion occurred.Two hours following the procedure the patient experienced slight dizziness.Echocardiography diagnosed an effusion approximately 15 mm circular in the front of the right atrium and right ventricle.A pericardial effusion was performed to stabilize the patient.There were no performance issues with any abbott device.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was not reviewed as the batch number was not available.Based on the information received, the cause of the reported pericardial effusion could not be conclusively determined.
Event or Problem Description
A pericardiocentesis was performed to stabilize the patient.

• Brand Name: INQUIRY¿ STEERABLE DIAGNOSTIC CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 2375 morse ave; irvine CA 92614
• MDR Report Key: 9097466
• Report Number: 2030404-2019-00095
• Device Sequence Number: 16819452
• 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): 10/03/2019

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 Model Number: IBI-81107
• Device Catalogue Number: IBI-81107
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/30/2019
• Supplement Date Received by Manufacturer: 09/20/2019
• Initial Report FDA Received Date: 09/20/2019
• Supplement Report FDA Received Date: 10/03/2019
• 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, SENSOR ENABLED¿; FLEXABILITY¿ ABLATION CATHETER, SENSOR ENABLED¿; INQUIRY¿ STEERABLE DIAGNOSTIC CATHETER X2
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Weight: 97