MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. PRESSUREWIRE; WIRE, GUIDE, CATHETER

Model Number X

Device Problems Misconnection (1399); Device Inoperable (1663)

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

Event Date 04/13/2018

Event Type  malfunction  

Event Description

Pressurewire x was introduced into patient's coronary artery.Upon completing the initial setup and advancing the wire into the distal portion of the artery, the equipment failed and was not able to reconnect to the st.Jude device.Wire was removed from the patient's body.New pressure wire x was opened and worked correctly.Case was continued with no further issues.Coronary pressure wire.

• Brand Name: PRESSUREWIRE
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 7560534
• MDR Text Key: 109786474
• Report Number: 7560534
• 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: 05/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• 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: 6143020
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/25/2018
• Event Location: Hospital
• Date Report to Manufacturer: 05/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 70 YR