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 Codes	Mitral Insufficiency (1963); Tissue Damage (2104)
Date of Event	02/05/2020
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: 3005334138-2020-00258, 3005334138-2020-00260.Following a ventricular tachycardia ablation procedure the patient developed severe mitral insufficiency.Ablation procedures were performed on (b)(6) 2019 and (b)(6) 2019 and no performance issues were noted with any abbott device during either procedure.In (b)(6) 2020 the patient was diagnosed with severe mitral insufficiency due to a ruptured chorda that may have been a result of the ablation procedures.The patient underwent a mitral clip procedure and was discharged home on (b)(6) 2020 in stable condition.

• 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: 10206508
• Report Number: 3005334138-2020-00259
• Device Sequence Number: 19623712
• Product Code: OAD
• UDI-Device Identifier: 05415067020086
• UDI-Public: 05415067020086
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 06/29/2020

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: 06/18/2020
• Initial Report FDA Received Date: 06/29/2020
• 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: FLEXABILITY SE CATHETER X2
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Weight: 103