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

Model Number X

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/06/2017

Event Type  malfunction  

Event Description

Pressure wire was turned on and connected initially but prior to advancing, st.Jude machine was unable to relocate the wire and became disconnected.We were unable to reconnect the wire after this.Wire never entered the body.No harm to the patient - a new wire was opened and used with no further incident.

• Brand Name: PRESSUREWIRE¿
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; saint paul MN 55117
• MDR Report Key: 6756492
• MDR Text Key: 81485641
• Report Number: 6756492
• 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: 07/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Device Model Number: X
• Device Catalogue Number: C12059
• Device Lot Number: 5905169
• 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: 07/12/2017
• Event Location: Hospital
• Date Report to Manufacturer: 07/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 75 YR