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

Model Number 100015555

Device Problem Failure of Device to Self-Test (2937)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/13/2019

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission. .

Event Description

During the procedure, a clinically significant delay occurred.When attempting to ablate, the amber light emitted from the amplifier and the ablation catheter would no longer function.The amplifier was reset, the patches were verified, and a non-abbott catheter was attempted with no resolution.A non-abbott mapping system was used causing a two hour delay in procedure.The procedure was completed successfully with no adverse consequences to the patient.

Manufacturer Narrative

One ensite velocity¿ system velocity amplifier was returned for investigation.Visual inspection revealed bent electrical contact pins within the genconnect connector.Power was applied to the returned amplifier which successfully completed the post (power on self-test) and the system status light changed to green.A review of the system log files captured on the reported event date revealed multiple and repeated voltage out of range and temperature shutdown faults stored, which confirms the reported issue.No additional functional testing was performed due to the bent electrical contact pins.The root cause was isolated to the catheter amplifier pca (printed circuit assembly) located in the slot 6 location.Based on the information provided to abbott and the investigation performed, the root cause of the reported ablation issue and subsequent procedure delay was isolated to abnormal functionality of the catheter amplifier board at the slot six location.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with abbott specifications and procedures.

• Brand Name: ENSITE VELOCITY SYSTEM VELOCITY AMPLIFIER
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 9497464
• MDR Text Key: 172254635
• Report Number: 2184149-2019-00253
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05414734210713
• UDI-Public: 05414734210713
• Combination Product (y/n): N
• PMA/PMN Number: K160187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 100015555
• Device Catalogue Number: 100014514
• Device Lot Number: 5185930
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other