MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. VIEWMATE¿ Z CATHETER INTERFACE MODULE; SYSTEM, SIGNAL ISOLATION

Model Number H701374

Device Problem Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/24/2019

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission. .

Event Description

Related manufacturing ref: 3004189859-2019-00003, 3008452825-2019-00561.During a left atrial appendage closure procedure, the system displayed a "overheating error" message and the procedure was canceled.There were no adverse consequences to the patient due to the cancellation.

Manufacturer Narrative

One viewmate¿ z catheter interface module was received for investigation.The catheter interface module and p9-3ic was connected to the zs3 console and the image appeared on the screen of the ultrasound console.There was no issue detected during this investigation.Based on the information provided to abbott and the investigation performed, the reported error message and subsequent procedure cancellation was unable to be confirmed.The returned product functioned properly during the evaluation.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.

• Brand Name: VIEWMATE¿ Z CATHETER INTERFACE MODULE
• Type of Device: SYSTEM, SIGNAL ISOLATION
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 9283997
• MDR Text Key: 165223656
• Report Number: 2184149-2019-00209
• Device Sequence Number: 1
• Product Code: DRJ
• Combination Product (y/n): N
• PMA/PMN Number: K120703
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/14/2020

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: H701374
• Device Catalogue Number: H701374
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/24/2019
• Initial Date FDA Received: 11/06/2019
• Supplement Dates Manufacturer Received: 11/19/2019; 02/14/2020; 02/14/2020
• Supplement Dates FDA Received: 11/19/2019; 02/14/2020; 02/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: VIEWFLEX ICE CATHETER; VIEWMATE Z ULTRASOUND CONSOLE; VIEWFLEX ICE CATHETER; VIEWMATE Z ULTRASOUND CONSOLE
• Patient Outcome(s): Other