MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LVAS SURGICAL HAND TOOLS, INT; VENTRICULAR (ASSIST) BYPASS

Model Number	10002222INT
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.
Event or Problem Description
It was reported that when using heartmate 3¿ lvad surgical hand tool during the implant procedure the tool handle separated.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: evaluation of the returned unlock tool confirmed the reported tool handle separation.A manufacturing analysis task was initiated to address tool handle separation during implant procedure.The issue was determined to be related to the tool supplier, and a quality alert was extended to the supplier to notify them of the observed issue.A further root cause for the observed issue could not be conclusively determined through the supplier's analysis.Abbott in-process dhr review: the lot number of the heartmate 3 lvas surgical hand tool was not provided.However, part number 10001795 went into 5 assembly (10002222int) lots within the date range for when the customer received the part (12oct2015 ¿ 03mar2017).The 5 assembly lot numbers are 162138, 162141, 163416, 182030, and 182768.Ppe is unable to conclusively determine which customer order/date is applicable to this part.The device history record (dhr) was reviewed for these 5 assembly lots.All manufacturing and inspection procedures for the unit were completed and passed.Abbott receiving inspection dhr review: the device history record (dhr) was reviewed for lot 20154858.Per dhr review the hm3, surgical tools, unlock tool received under lot 20154858 did pass the inspection performed at abbott incoming inspection.The current revisions of the instructions for use (ifu) and patient handbook can also be found on the electronic ifu (eifu) page of the abbott website.The heartmate iii¿ lvas surgical hand tools ifu, rev.C, is currently available.Section 1 of this ifu explains that the heartmate 3 unlock tool is an optional tool that can be used to open the slide lock mechanism.Section 3 of this ifu instructs to inspect each tool for damage or wear prior to use.Do not use the tool if damage or wear is detected.The surgical procedures section of heartmate 3 left ventricular assist system (lvas) ifu, rev.B, states to use a sterile surgical tool to unlatch the slide lock, if necessary.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 LVAS SURGICAL HAND TOOLS, INT
• Common Device Name: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 20268885
• Report Number: 2916596-2024-05982
• Device Sequence Number: 3393341
• Product Code: DSQ
• UDI-Device Identifier: 05415067038418
• UDI-Public: (01)05415067038418
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: P160054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 10002222INT
• Device Catalogue Number: 10002222INT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2024
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown