MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. MECHANICAL VALVE SIZERS; SIZER, HEART-VALVE, PROSTHESIS

Device Problems Break (1069); Material Fragmentation (1261)

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

Event Date 06/26/2017

Event Type  malfunction  

Event Description

One of the st jude plastic heart valve sizer broke into pieces while dr.Was using it to size mitral valve.Dr.Was able to gather all little pieces.Additional info: the last time this tray was modified in the system was 4 years ago, but pieces could have been replaced since then without record of that.Last year the tray was processed approximately 20 times at a rate of 6:45 at 270 degrees.

• Brand Name: MECHANICAL VALVE SIZERS
• Type of Device: SIZER, HEART-VALVE, PROSTHESIS
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 6720962
• MDR Text Key: 80282839
• Report Number: 6720962
• Device Sequence Number: 1
• Product Code: DTI
• 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: 06/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Other Device ID Number: MECHSZAO
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/27/2017
• Event Location: Hospital
• Date Report to Manufacturer: 06/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 38 YR