MAUDE Adverse Event Report: ST. JUDE MEDICAL 23 MM MECHANICAL HEART VALVE ROTATABLE

Model Number 23AGFN-756

Device Problems Break (1069); Positioning Problem (3009)

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

Event Date 09/09/2014

Event Type  malfunction  

Event Description

St.Jude medical mechanical heart valve broke upon rotation of valve in patient.

• Brand Name: 23 MM MECHANICAL HEART VALVE ROTATABLE
• Type of Device: 23 MM MECHANICAL HEART VALVE ROTATABLE
• Manufacturer (Section D): ST. JUDE MEDICAL; st. paul 55117
• MDR Report Key: 4231866
• MDR Text Key: 5002839
• Report Number: MW5038971
• Device Sequence Number: 1
• Product Code: LWQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/16/2019
• Device Model Number: 23AGFN-756
• Device Catalogue Number: 23AGFN-756
• Other Device ID Number: 100080869
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 58 YR