MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA 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	05/17/2018
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 cardiac perforation could not be conclusively determined.Per the ifu, vascular perforation is an inherent risk of any electrode placement.
Event or Problem Description
Related manufacturing ref: 2030404-2018-00043, 3008452825-2018-00180, 3005334138-2018-00160, 3008452825-2018-00181, 3005334138-2018-00161.During a pulmonary vein isolation procedure.A cardiac perforation occurred in the superior septal left atrium.During geometry collection, the lower right branches of the pulmonary vein were difficult to engage due a common right pulmonary ostium.After geometry was collected, an ablation line encircling the right vein was attempted and the patient became hypotensive.An ultrasound revealed an effusion in the superior septal left atrium for which a pericardiocentesis was performed to stabilize the patient.Further ablation was aborted.There were no performance issues with the abbott device.

• Brand Name: FLEXABILITY¿ABLATION CATHETER, UNI-D, CURVE D
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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: 7604672
• Report Number: 3008452825-2018-00175
• Device Sequence Number: 1422498
• 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
• Report Date (Section B): 06/15/2018

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: 12/31/2020
• Device Model Number: A701157
• Device Catalogue Number: A701157
• Device Lot Number: 6279487
• 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: 05/18/2018
• Initial Report FDA Received Date: 06/15/2018
• 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: BRK-1 TRANSSEPTAL NEEDLE; FLEXABILITY ABLATION CATHETER; RESPONSE EP CATHETER; SWARTZ BRAIDED INTRODUCER SL0; THERAPY ABLATION CATHETER
• Outcome Attributed to Adverse Event: Required Intervention