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

Model Number 600073552

Device Problem Smoking (1585)

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

Event Date 01/20/2022

Event Type  malfunction  

Event Description

During the cryoablation procedure, it was noticed that a soft bang was heard followed by light smoke.The amplifier was then switched off and an attempt was made to restart it, without success.The procedure could be completed normally as the amplifier was not needed for this procedure.

Manufacturer Narrative

Additional information: d9, g3, h2, h3.One ensite velocity¿ amplifier was received for evaluation.Visual inspection revealed the front panel ports, chassis, and labels were free of physical damage.Visual inspection of the rear, the internals and the power input module revealed there was ingress of a liquid (saline), that entered into the rear of the chassis, and then shorted the power input module hot to ground.The power input module was physically damaged from an electrical source.Power was bypassed using a known good power input module and the amplifier passed power-on-self-test (post).The amplifier went status ready ¿green¿ and communicated with the test ensite computer.Evaluation of the board status showed all boards status were green indicating passing results.The power inductor was noted to pass the evaluation, however, evaluation also recommends to replace the ac power inductor.Both fuses were tested and were successful.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No non-conformances associated with the reported event were identified.Based on the information provided to abbott and the investigation performed, the root cause of the event was attributed to ingress of a liquid to the power input module, from an undetermined event.

• Brand Name: ENSITE¿ VELOCITY¿ CARDIAC MAPPING SYSTEM
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• 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: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13384880
• MDR Text Key: 284621900
• Report Number: 2184149-2022-00027
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05414734210713
• UDI-Public: 05414734210713
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K141050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 600073552
• Device Catalogue Number: 100014514
• Device Lot Number: 7857021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2021
• 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