MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. LIVEWIRE ELECTROPHYSIOLOGY CATHETER DECAPOLAR, MEDIUM SWEEP ELECTRODE SPACING 2; CATHETER, STEERABLE

Model Number	401940
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	04/26/2020
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 incident could not be conclusively determined.
Event or Problem Description
Related manufacturer reference number: 3005334138-2020-00200, 3008452825-2020-00251, 3005334138-2020-00201, 3008452825-2020-00252.Two days following an ablation procedure, the patient developed a cerebrovascular accident.The circumferential four pulmonary vein isolation and cavotricuspid isthmus ablation procedure was performed on (b)(6) 2020 with no reported issues.The patient was anticoagulated during the procedure with an active clotting time value of greater than 300, and there were no performance issues with any abbott device.On (b)(6) 2020 a head ct and mri were performed, revealing an acute-to-subacute cerebral infarction over the right frontal and temporal opercula region.It was suspected that there was a thrombus in the cortical bifurcation of the inferior segment of the right middle cerebral artery (mca).The patient was hospitalized for iv fluids and anticoagulants, remaining in stable condition.A repeat head ct revealed no intracranial hemorrhage and the patient was discharged on (b)(6) 2020 with no residual neurological deficits.

• Brand Name: LIVEWIRE ELECTROPHYSIOLOGY CATHETER DECAPOLAR, MEDIUM SWEEP ELECTRODE SPACING 2
• Common Device Name: CATHETER, STEERABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• MDR Report Key: 10088465
• Report Number: 2182269-2020-00048
• Device Sequence Number: 11494165
• Product Code: DRA
• UDI-Device Identifier: 05414734202688
• UDI-Public: 05414734202688
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K022380
• 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): 05/26/2020

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: 03/31/2022
• Device Model Number: 401940
• Device Catalogue Number: 401940
• Device Lot Number: 6892835
• 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: 05/07/2020
• Initial Report FDA Received Date: 05/26/2020
• 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: Required Intervention
• Patient Age: 63 YR
• Patient Weight: 54