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

Model Number C12059

Device Problems Defective Component (2292); Pressure Problem (3012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/05/2017

Event Type  malfunction  

Event Description

The pressure wire x by st.Jude was defective.Once inserted into the body we discovered after three minutes that the pressure wire was not monitoring the pressures correctly.The pressure continued to drift as we tried to equalize and continued to give an error message.We removed the pressure wire five minutes after initial insertion and got a new one.

• Brand Name: PRESSUREWIRE X
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; saint paul MN 55117
• MDR Report Key: 6684119
• MDR Text Key: 78980970
• Report Number: 6684119
• 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: 06/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Device Model Number: C12059
• Device Catalogue Number: C12059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/06/2017
• Event Location: Hospital
• Date Report to Manufacturer: 06/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 60 YR