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

Model Number 100015555

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/09/2021

Event Type  malfunction  

Manufacturer Narrative

One ensite velocity¿ system velocity amplifier was received for analysis.The amplifier was powered on to a green led status.This indicates the amplifier successfully passed the power on self-test (post) and communication was established.The field reported event was confirmed as review of error logs identified several temperature-out-of-range issues toward the cath amp board on slot 6.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.Based on the information received and investigation performed, the root cause was isolated to the cath amp board on slot 6.

Event Description

Related manufacturer report numbers: 3005334138-2021-00089, 2184149-2021-00044 during an a-flutter ablation procedure, the amplifier would blink yellow when coming on ablation.The amplifier error message "logout and restart amplifier and system" was noted.The dws, generator and amplifier were all power cycled but the issue remained.The catheter was replaced and cryo was used to continue the procedure.Upon further inspection, bent pins were noted on the navx connector on the amplifier.In addition, the ensite dws secondary monitor output (via display port) was not working.The secondary image was unable to come up on siemens monitor.The display port dongle was replaced twice, in addition to replacing the dvi to dvi cable, but that did not resolve the issue.The set up was connected on the primary monitor port and the image was able to be displayed.The procedure was delayed due to these issues.There were no adverse patient consequences.

• Brand Name: ENSITE VELOCITY SYSTEM VELOCITY AMPLIFIER
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 11371721
• MDR Text Key: 233258338
• Report Number: 2184149-2021-00043
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05414734210713
• UDI-Public: 05414734210713
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100015555
• Device Catalogue Number: 100014514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: ENSITE DWS; TACTICATH SE