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
Medical Device Problem Code	Arcing (2583)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/24/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: ULTRASONIC PULSED DOPPLER IMAGING SYSTEM
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 9540330
• Report Number: 2184149-2019-00259
• Device Sequence Number: 2664125
• Product Code: IYN
• UDI-Device Identifier: 05415067002907
• UDI-Public: 05415067002907
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K120703
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 100043720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2019
• Initial Report FDA Received Date: 01/02/2020
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Weight: 96