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

Model Number EE3000

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/12/2020

Event Type  Injury  

Manufacturer Narrative

Further information was requested but not received.The results/ method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

During a radiofrequency ablation procedure, the physician found fault when the amplifier was used and the case was cancelled.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined that no non-conformances were identified that are related to the reported event.Based on the information received, the cause of the reported cancellation remains unknown.

Manufacturer Narrative

One ensite velocity¿ system velocity amplifier was received for analysis.Visual inspection of the returned product confirmed all input and output connectors are free of physical damage and all labeling is legible and correctly oriented.Power was applied and the returned amplifier did not successfully complete the post (power on self-test); a solid amber system status light displayed.A review system log files and system board status revealed the catheter amplifier pca (printed circuit assembly) displays multiple and repeated post bio impedance errors and the board is no longer active in board status.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined that no non-conformances were identified that are related to the reported event.Based on the information provided to abbott and the investigation performed, the root cause of the field reported issue was isolated to the catheter amplifier board located in the slot thirteen position.

• 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
• MDR Report Key: 10453527
• MDR Text Key: 204356273
• Report Number: 2184149-2020-00127
• 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,Followup
• Report Date: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EE3000
• Device Catalogue Number: 100014514
• Device Lot Number: 6831043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 48 YR