MAUDE Adverse Event Report: ST. JUDE MEDICAL FLEXABILITY¿ABLATION CATHETER, UNI-D, CURVE D; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number	A701157
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	09/13/2018
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 could not be conclusively determined. per the ifu, cardiac perforation is a known risk during the use of this device.
Event or Problem Description
During a pulmonary vein isolation procedure, a pericardial effusion was noted.Following geometry collection, the ablation catheter appeared outside of the geometry during fusion.The two remaining catheters appeared within their anatomical locations.An echocardiogram was performed and revealed a pericardial effusion.A pericardiocentesis was performed which stabilized the patient.There were no performance issues with any abbott device.
Event or Problem Description
Related manufacturing ref: 3005334138-2018-00359.

• Brand Name: FLEXABILITY¿ABLATION CATHETER, UNI-D, CURVE D
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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: 7918817
• Report Number: 3008452825-2018-00339
• Device Sequence Number: 13789910
• Product Code: OAD
• UDI-Device Identifier: 05415067011497
• UDI-Public: 05415067011497
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P110016
• 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): 10/12/2018

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: 01/31/2021
• Device Model Number: A701157
• Device Catalogue Number: A701157
• Device Lot Number: 6334008
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/13/2018
• Supplement Date Received by Manufacturer: 09/13/2018
• Initial Report FDA Received Date: 09/28/2018
• Supplement Report FDA Received Date: 10/12/2018
• 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: SWARTZ INTRODUCER
• Outcome Attributed to Adverse Event: Required Intervention