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	10/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the pump unlock tool was broken.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is complete.
Additional Manufacturer Narrative
E1: reporter address and email were not available.Manufacturer's investigation conclusion: visual inspection of the returned unlock tool confirmed the report of the unlock tool handle breaking.The shaft and handle of the unlock tool were returned for evaluation.Visual examination of the proximal end of the unlock tool shaft revealed that the handle had completely separated from the shaft.Discoloration was noted inside the welded area of the shaft and the handle.A specific cause for these findings could not be conclusively determined through this evaluation.This issue has been previously investigated by abbott manufacturing and the part supplier.Although steps have been taken to prevent reoccurrence, abbott will continue to monitor this issue.The unlock tools are manufactured and supplied by an outside vendor who maintains the device history records.Additionally, the lot number of the tool was not provided.The heartmate 3 lvas surgical hand tools are shipped with heartmate 3 lvas surgical hand tools instructions for use (ifu).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 visually inspect the instruments before each use.Do not use the instrument if there are signs of corrosion, discoloration, and/or pitting, or if mechanical wear is noted, particularly in areas where the instrument joins with heartmate 3 components.Prior to use, inspect each tool for damage or wear.The surgical procedures section of hm3 ifu, 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: 18060498
• Report Number: 2916596-2023-07813
• Device Sequence Number: 17839748
• Product Code: DSQ
• UDI-Device Identifier: 05415067038418
• UDI-Public: 05415067038418
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/29/2024

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
• 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: 10/30/2023
• Supplement Date Received by Manufacturer: 02/27/2024
• Initial Report FDA Received Date: 11/02/2023
• Supplement Report FDA Received Date: 02/29/2024
• 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