MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. PRESSUREWIRE¿; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number RECEIVER

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/03/2018

Event Type  malfunction  

Event Description

Ffr pressure wire x (st jude medical) did not work properly; the console was not working properly after troubleshooting and we ended up using volcano ffr instead.No harm to the patient and the console was taken out of service.Receiver was diagnosed as the problem and was subsequently replaced.

• Brand Name: PRESSUREWIRE¿
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 7511215
• MDR Text Key: 108179738
• Report Number: 7511215
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/09/2018

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
• Device Operator: No Information
• Device Model Number: RECEIVER
• Device Catalogue Number: C17040
• Other Device ID Number: 54601 MEDICAL ENGINEERING CON
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/09/2018
• Event Location: Hospital
• Date Report to Manufacturer: 05/09/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 70 YR