MAUDE Adverse Event Report: ST. JUDE MEDICAL FLEXABILITY ABLATION CATHETER, BI-D, CURVE D-F; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number	A701125
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	01/19/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
During an angioplasty procedure, while mapping, the electrocardiogram began to show st segment elevation and low artery pressure.At this time mapping was stopped and medication was administered to help regulate blood pressure.An ultrasound was performed revealing the coronary artery was not functioning properly and the patient was transferred to the hemodynamics sector for evaluation.While waiting for transport, the patient went into ventricular fibrillation and a cardiac massage was started and a shock with a defibrillator was performed to stabilize the patient.The patient was transferred to hemodynamics and a dissection of the right coronary artery was observed which was thought to be spontaneous.A stent was placed in the right coronary to stabilize the patient and the patient was discharged two days following the procedure.There were no performance issues with any abbott devices.
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 incident could not be conclusively determined.

• Brand Name: FLEXABILITY ABLATION CATHETER, BI-D, CURVE D-F
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• 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: 11332052
• Report Number: 3008452825-2021-00077
• Device Sequence Number: 3416483
• Product Code: OAD
• UDI-Device Identifier: 05415067011114
• UDI-Public: 05415067011114
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P110016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2021

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: 10/31/2021
• Device Model Number: A701125
• Device Catalogue Number: A701125
• Device Lot Number: 6723881
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/20/2021
• Supplement Date Received by Manufacturer: 02/23/2021
• Initial Report FDA Received Date: 02/16/2021
• Supplement Report FDA Received Date: 02/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR