MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE VELOCITY¿ SYSTEM VELOCITY AMPLIFIER; ELECTROPHYSIOLOGY CARDIAC MAPPING SYSTEM

Model Number 100015555

Device Problem Image Display Error/Artifact (1304)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/21/2018

Event Type  Injury  

Event Description

Related manufacturer report number: 2184149-2018-00111.During the procedure, the ablation catheter appeared elongated on the display; however, the electrograms and the other catheters displayed normally.The ablation catheter was replaced and the amplifier was power cycled but the issue remained.As a result, the procedure was aborted.

Manufacturer Narrative

One ensite velocity¿ system velocity amplifier was received for analysis.Visual inspection revealed the connectors and labels appeared to have no physical damage.All of the mounting hardware was secured.Normal wear was observed on the exterior enclosure.When the amplifier was powered on, it completed a power on self-test (post) and the green led was illuminated.The log files were reviewed and revealed the catheter amplifier board in slot 13 had various post bio failures for channel 6, which was replicated in the board tester.The issue was isolated to the integrated circuit at location fu101.When the component was cooled, the board didn't pass post.Additionally, the patch impedance test didn't pass during functional testing which was isolated to the ecg board.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information provided to abbott and the investigation performed, the root cause of the reported event was isolated to the catheter amplifier board in slot 13 and the ecg board.The conditions of these boards would cause the amplifier to function as reported.

• Brand Name: ENSITE VELOCITY¿ SYSTEM VELOCITY AMPLIFIER
• Type of Device: ELECTROPHYSIOLOGY CARDIAC MAPPING SYSTEM
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: elizabeth boltz ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 7701508
• MDR Text Key: 114400520
• Report Number: 2184149-2018-00110
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05414734210713
• UDI-Public: 05414734210713
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/24/2018

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
• Device Operator: Health Professional
• Device Model Number: 100015555
• Device Lot Number: 4962002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/21/2018
• Initial Date FDA Received: 07/18/2018
• Supplement Dates Manufacturer Received: 07/18/2018
• Supplement Dates FDA Received: 07/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: AMPERE GENERATOR; FLEXABILITY CATHETER
• Patient Outcome(s): Other