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

Model Number X

Device Problem Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/06/2018

Event Type  malfunction  

Event Description

Device was placed in vessel, and pa pressure was visible initially.When the time came to initiate measurements arterial pressure waveform spontaneously disappeared.Wire was removed intact with no harm to patient.

• Brand Name: PRESSUREWIRE¿
• 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: 7959892
• MDR Text Key: 123569244
• Report Number: 7959892
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/03/2018

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: Health Professional
• Device Model Number: X
• Device Catalogue Number: C12059
• Device Lot Number: 6356208
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/03/2018
• Date Report to Manufacturer: 10/12/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 31390 DA