MAUDE Adverse Event Report: ST. JUDE MEDICAL MASTERS; HEART-VALVE, MECHANICAL

Catalog Number 27MJ-501

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Date 01/20/2014

Event Type  malfunction  

Event Description

St.Jude mechanical valve leaflets broke off while positioning the valve.

• Brand Name: MASTERS
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117 998
• MDR Report Key: 3605201
• MDR Text Key: 4176717
• Report Number: 3605201
• Device Sequence Number: 1
• Product Code: LWQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Catalogue Number: 27MJ-501
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/24/2014
• Event Location: Hospital
• Date Report to Manufacturer: 02/04/2014
• Patient Sequence Number: 1
• Patient Age: 56 YR