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

Model Number	A-FASE-DF
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
During an atrioventricular node ablation, the catheter was advanced into the left ventricle for consolidation lesions when it became entangled in the struts of the non abbott (sapien tavr) valve.Mutiple attempts were made to remove the catheter tip from the valve without success.The patient was transferred to surgery to retrieve the device.
Event or Problem Description
The patient was transferred to the cath labe at a different hospital and they attempted to extract the ablation catheter from the sapien valve unsuccessfully.The patient was then moved to the operating room where the catheter was successfully removed and patient was doing well post surgery.
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 entrapment remains unknown.
Event or Problem Description
The patient was doing well post surgery.

• Brand Name: FLEXIBILTY SE
• 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
• Manufacturer (Section G): 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
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17143958
• Report Number: 3008452825-2023-00261
• Device Sequence Number: 16627334
• Product Code: OAD
• UDI-Device Identifier: 05415067020062
• UDI-Public: 05415067020062
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/14/2023

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 Model Number: A-FASE-DF
• Device Catalogue Number: A-FASE-DF
• Device Lot Number: 8987708
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2023
• Supplement Date Received by Manufacturer: 06/22/2023; 07/13/2023
• Initial Report FDA Received Date: 06/16/2023
• Supplement Report FDA Received Date: 06/23/2023; 07/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 143 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White