MAUDE Adverse Event Report: ABBOTT - THORATEC CORP. THORATEC HEARTMATE 3 LVAD - CORING TOOL; VENTRICULAR (ASSIST) BYPASS

Model Number REF NO. 106524 US

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/22/2019

Event Type  malfunction  

Event Description

In operating room for impella removal, temporary closure of chest (one wire), and placement of lvad.When driveline for the lvad was exteriorized, a small plastic flange of the driveline adapter was noted to have fractured.Examination throughout the driveline tunnel tract, as well as in the mediastinum prior to closure, failed to identify the small plastic fragment.

• Brand Name: THORATEC HEARTMATE 3 LVAD - CORING TOOL
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): ABBOTT - THORATEC CORP. ; pleasanton CA 94588
• MDR Report Key: 8424788
• MDR Text Key: 139078023
• Report Number: MW5084926
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: REF NO. 106524 US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 71