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

Model Number	A701158
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Codes	Death (1802); Cardiac Perforation (2513)
Date of Event	01/21/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.Further information regarding the event were requested but not received.
Event or Problem Description
Related manufacturer reference: 2184149-2020-00014, 3008452825-2020-00073.During a premature ventricular contraction procedure, a cancellation, tamponade and subsequent death occurred.The cs catheter and the his catheter were introduced via the femoral vein into the coronary sinus and at the his bundle.During introduction, excessive catheter movement was observed.A flexibility was introduced via retrograd access into the aorta, and the latmap and a geometry of the lvot was collected.System reference and respiration compensation were utilized and the update respiration was off.Ablation was started at the earliest point in the lvot.Due to the catheter movement, the cs 5 was utilized for reference.Fluoro was not used to locate the catheters following the shift.During preparation of changing from arterial access to venous access the physician noticed abnormal steering of the flexibility.Following ablation in the lvot, there were still pvcs.The visualization of the ablation catheter was not in the correct location, and system reference was utilized and a shift occurred.The cs shadow and current cs position were not aligned.The physician decided to go in rvot and a flexibility was introduced.A model of rvot and latmap was collected.The ablation of the earliest point in rvot was started and pvcs were still present.Due to the shift, the procedure was not completed.The shift was due to instability of the ensite system or the patient, which is why they procedure was not completed.Following the procedure, in the recovery room, the patient noted feeling of nausea.An echocardiogram confirmed a tamponade located mainly rn/ra and was circular, and a pericardiocentesis was performed.The coronary sinus catheter (inquiry) was the physician's suspected cause for the tamponade.During treatment of tamponade resuscitation was necessary.The patient was deceased.
Additional Manufacturer Narrative
One flexability¿ ablation catheter was returned for investigation.Electrodes 1-4 and the thermocouples met specifications for acceptable resistance values with no open or short circuits detected.The catheter deflected when actuating the steering mechanism and the curve dimensions met specifications.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported issue remains unknown.

• Brand Name: FLEXABILITY¿ ABLATION CATHETER, UNI-D, CURVE 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: 9677276
• Report Number: 3008452825-2020-00066
• Device Sequence Number: 2664100
• Product Code: OAD
• UDI-Device Identifier: 05415067011503
• UDI-Public: 05415067011503
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P110016
• 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,Followup
• Report Date (Section B): 03/03/2020

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: 07/31/2022
• Device Model Number: A701158
• Device Catalogue Number: A701158
• Device Lot Number: 7156611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/21/2020
• Supplement Date Received by Manufacturer: 02/13/2020
• Initial Report FDA Received Date: 02/06/2020
• Supplement Report FDA Received Date: 03/03/2020
• 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: ENSITE VELOCITY¿ DWS7 V.5.0.1; INQUIRY¿ STEERABLE EP CATHETER; ENSITE VELOCITY¿ DWS7 V.5.0.1; INQUIRY¿ STEERABLE EP CATHETER
• Outcome Attributed to Adverse Event: Death