MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. THERAPY¿ ABLATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number	IBI-83366
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	06/14/2019
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 could not be conclusively determined.Per the ifu, cardiac perforation is a known risk during the use of this device.
Event or Problem Description
Related manufacturing ref: 3008452825-2019-00308.During an incessant atrial tachycardia procedure, a pericardial effusion occurred.Three non-abbott diagnostic catheters were placed in the coronary sinus, his bundle , and the right ventricle.Mapping was completed and transseptal was going to be performed.During preparation for transseptal the patient went into atrial fibrillation resulting in hypotension.An ice catheter revealed fluid in the pericardium.Heparin was reversed and the procedure was cancelled.The patient is in stable condition.There were no performance issues with any abbott device.

• Brand Name: THERAPY¿ ABLATION CATHETER
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 2375 morse ave; irvine CA 92614
• MDR Report Key: 8752378
• Report Number: 2030404-2019-00049
• Device Sequence Number: 2280617
• Product Code: LPB
• UDI-Device Identifier: 05414734306935
• UDI-Public: 05414734306935
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P040014
• 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): 07/02/2019

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: 01/31/2022
• Device Model Number: IBI-83366
• Device Catalogue Number: IBI-83366
• Device Lot Number: 6831293
• 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: 06/14/2019
• Initial Report FDA Received Date: 07/02/2019
• 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: AGILIS STEERABLE INTRODUCER
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR
• Patient Weight: 75