MAUDE Adverse Event Report: ST. JUDE MEDICAL FLEXABILITY ABLATION CATHETER, SENSOR ENABLED; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number	A-FASE-FJ
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	06/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event of cerebral injury was reported.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 cva may have been procedure related.
Event or Problem Description
Following the procedure, the patient experienced a potential cerebrovascular injury, respiratory failure, and elevated white blood cell count.Post ablation, the patient had respiratory secretions and blockages of four lobes in the lungs.The secretions were removed and diuresis was performed and the patient was successfully extubated.The respiratory compromise was attributed to volume overload during the procedure and general anesthesia.Additionally, the patient's white blood cell count (wbc) was elevated, however this occurred due to intra-aortic balloon pump insertion.Antibiotics were administered and the wbc count decreased.The patient also complained of diplopia post procedure and a ct was performed which revealed no evidence of acute infarct or intracranial hemorrhage but a small chronic left cerebellar infarct was present.The patient's act was between 268 and 334 throughout the procedure.The patient was administered heparin and statin and the symptoms resolved after the patient was discharged.The patient had a history of transient ischemic attacks with no residual deficits.Echo was performed a week before the procedure to rule out thrombus and ice was performed prior to initiating mapping and no thrombus was observed.The cause of the cerebral injury is unknown and there were no contributing anomalies during the procedure.The patient is in stable condition.There were no performance issues with any abbott device.

• Brand Name: FLEXABILITY ABLATION CATHETER, SENSOR ENABLED
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10285808
• Report Number: 3005334138-2020-00294
• Device Sequence Number: 19005174
• Product Code: OAD
• UDI-Device Identifier: 05415067020086
• UDI-Public: 05415067020086
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P110016
• 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): 07/16/2020

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: 06/30/2021
• Device Model Number: A-FASE-FJ
• Device Catalogue Number: A-FASE-FJ
• Device Lot Number: 6538247
• 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: 06/22/2020
• Initial Report FDA Received Date: 07/16/2020
• 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: Other