MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE VELOCITY CARDIAC MAPPING SYSTEM; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	100149282
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During an atrial fibrillation ablation (af) procedure, the catheters were consistently drifting while having a wave-like motion which caused a significant delay.Following advancement into the left atrium, the catheter had a wave-like motion to it.The catheter was exchanged and the same issue was noted.Troubleshooting included the disabling magnetics, swapping the tactisys, generator, all cables, and multiple system reboots were performed.A third catheter was used to complete the procedure with no adverse consequences to the patient.The procedure was an af ablation, but only cti ablation was performed.
Additional Manufacturer Narrative
The reported event of catheter drift could not be investigated as the device was not returned for analysis.Additionally, the study data was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined that no non-conformances were identified that are related to the reported event.The cause for the reported drift and subsequent delay remains unknown.

• Brand Name: ENSITE VELOCITY CARDIAC MAPPING SYSTEM
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 12206414
• Report Number: 2184149-2021-00230
• Device Sequence Number: 4377448
• Product Code: DQK
• UDI-Device Identifier: 05415067014573
• UDI-Public: 05415067014573
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K160187
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 100149282
• Device Catalogue Number: EE3000
• Device Lot Number: 6655869
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/23/2021
• Supplement Date Received by Manufacturer: 09/08/2021
• Initial Report FDA Received Date: 07/21/2021
• Supplement Report FDA Received Date: 09/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1