MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 SEALED OUTFLOW GRAFT WITH BEND RELIEF; VENTRICULAR (ASSIST) BYPASS

Model Number	105581US
Medical Device Problem Codes	Detachment of Device or Device Component (2907); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during pump preparation, the outflow graft was cut when the hemostat was placed.A new outflow graft was used for the procedure.The outflow graft and bend relief were to be sent back.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: evaluation of the returned outflow graft confirmed the cut in the distal portion of the outflow graft.The outflow graft and outflow graft bend relief were returned in like-new condition.Visual inspection of the distal end of the outflow graft revealed a cut in the graft approximately 9.5 inches from the graft attachment.The outflow graft bend relief appeared unremarkable.The hardware of the outflow graft and outflow graft bend relief were inspected, and no abnormalities were observed.Review of the available device history records for lot number 8278241 showed no deviations from manufacturing and qa (quality assurance) specifications.The heartmate 3 lvas ifu is currently available.Section 5 of this ifu contains instructions for unpacking the sealed outflow graft (5-15) and preparing the sealed outflow graft (5-16).Section 5 also states that during the implant process, a complete backup system (implant kit and external components) must be available on-site and in close proximity for use in an emergency.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 SEALED OUTFLOW GRAFT WITH BEND RELIEF
• 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: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 15668445
• Report Number: 2916596-2022-14705
• Device Sequence Number: 15045273
• Product Code: DSQ
• UDI-Device Identifier: 00813024013266
• UDI-Public: 00813024013266
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2022

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: Lay User/Patient
• Device Expiration Date: 04/13/2024
• Device Model Number: 105581US
• Device Catalogue Number: 105581US
• Device Lot Number: 8278241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2022
• 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: 10/14/2022
• Supplement Date Received by Manufacturer: 11/29/2022
• Initial Report FDA Received Date: 10/25/2022
• Supplement Report FDA Received Date: 11/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown