MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. VIEWFLEX¿ PLUS ICE CATHETER INTERFACE MODULE FOR VIEWMATE Z INTRACARDIAC ULTRASO; ULTRASONIC PULSED DOPPLER IMAGING SYSTEM

Model Number 100043720

Device Problem Arcing (2583)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/24/2019

Event Type  malfunction  

Manufacturer Narrative

One viewflex¿ plus ice catheter interface module for viewmate z intracardiac ultrasound console was received for investigation.Trace amounts of foreign material was identified on the transducer connector port.Disassembly was performed, and heavy amounts of saline deposits were identified on numerous internal assemblies with signs of arcing between electronic components.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information provided to abbott and the investigation performed, there was fluid ingress to the internal assemblies resulting in hardware damage.

Event Description

This event is being reported based on the analysis of the returned device. .

• Brand Name: VIEWFLEX¿ PLUS ICE CATHETER INTERFACE MODULE FOR VIEWMATE Z INTRACARDIAC ULTRASO
• Type of Device: ULTRASONIC PULSED DOPPLER IMAGING SYSTEM
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC. (AF-ST. PAUL); one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 9540330
• MDR Text Key: 178026719
• Report Number: 2184149-2019-00259
• Device Sequence Number: 1
• Product Code: IYN
• UDI-Device Identifier: 05415067002907
• UDI-Public: 05415067002907
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K120703
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100043720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2011
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Weight: 96