MAUDE Adverse Event Report: ST. JUDE MEDICAL ST. JUDE; VALVE SIZER

Model Number 905

Device Problem Component Missing (2306)

Patient Problem No Information (3190)

Event Date 07/15/2014

Event Type  Injury  

Event Description

Scrub nurse handed 27mm st jude sizer to surgeon: handle intact, scrub nurse received 27mm st jude sizer back from surgeon in two pieces with approx 1cm of plastic material missing from sizer.

• Brand Name: ST. JUDE
• Type of Device: VALVE SIZER
• Manufacturer (Section D): ST. JUDE MEDICAL; 6300 bee ave rd; ste 100 building two; austin TX 78746 583
• MDR Report Key: 3966362
• MDR Text Key: 4637002
• Report Number: MW5037472
• Device Sequence Number: 1
• Product Code: DTI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 905
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 110