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

Model Number 100014514

Device Problems Communication or Transmission Problem (2896); Failure of Device to Self-Test (2937)

Patient Problem Cardiac Perforation (2513)

Event Date 04/08/2020

Event Type  Injury  

Manufacturer Narrative

The results, method, and conclusion codes along with the investigation will be provided in the final report.

Event Description

Related manufacturer reference number: 3005334138-2020-00166.During a pulmonary vein isolation ablation procedure, a cardiac tamponade occurred.When ablation was being performed an amplifier error occurred, with the status light changing to flashing orange.In addition, the ablation catheter was no longer being displayed.The amplifier was replaced to resolve the issue however the patient had become hypotensive.An echocardiogram was performed revealing a cardiac tamponade, for which a pericardiocentesis was performed to stabilize the patient.

Manufacturer Narrative

One ensite velocity¿ system velocity amplifier was received for evaluation.Visual inspection revealed the connectors and labels appeared to have no physical damage.The amplifier was powered on and passed the power on self-test (post) with a green led status.Communication was established the test station.The field reported event was confirmed as review of error logs identified consistent board shutdowns towards cath amp board on slot 6.The root cause was isolated to 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 provided to abbott and the investigation performed, the root cause was isolated to the cath amp board on slot 6.

• 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: 10000161
• MDR Text Key: 189886381
• Report Number: 2184149-2020-00050
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05414734210713
• UDI-Public: 05414734210713
• Combination Product (y/n): N
• PMA/PMN Number: K141050
• 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: 05/08/2020

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: 100014514
• Device Catalogue Number: 100014514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/08/2020
• Initial Date FDA Received: 04/27/2020
• Supplement Dates Manufacturer Received: 04/29/2020
• Supplement Dates FDA Received: 05/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TACTICATH SE CATHETER
• Patient Outcome(s): Required Intervention