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

Model Number 600023001

Device Problem Material Twisted/Bent (2981)

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

Event Date 06/14/2021

Event Type  malfunction  

Event Description

During a pulmonary vein contraction procedure, a display issue occurred which caused a significant delay.Electrode d of the contact force catheter did not displayed properly on the navx image, but the signal was appropriate.The cables, catheter, and the generator were exchanged which did not resolve the issue.An ablation catheter was then obtained, however the issue remained.The amplifier port was found to have bent pins.The procedure was completed by using the catheter as diagnostic device with no consequences to the patient.

Manufacturer Narrative

One ensite velocity¿ system velocity amplifier was received for analysis.Visual inspection of the front panel genconnect connector revealed bent electrical contact pins, which confirmed the reported issue.The remaining input and output connectors were free of physical damage and all labeling is legible and correctly oriented.No functional testing was performed due to the physical damage previously noted.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 reported display issue and subsequent delay was isolated to a bent electrical contact pin at the genconnect connector at the front panel.

• 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: 12027210
• MDR Text Key: 261760701
• Report Number: 2184149-2021-00202
• Device Sequence Number: 1
• Product Code: DQK
• 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
• Report Date: 08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 600023001
• Device Lot Number: 7252127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1