MAUDE Adverse Event Report: THORATEC CORPORATION THORATEC® HEARTMATE 3¿; VENTRICULAR (ASSIST) BYPASS

Model Number	105581US
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2024
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 complete.
Event or Problem Description
It was reported that during pump preparation there was a defect visualized by the or nurse scrub technician on the outflow graft within the purple housing.Scratches were seen and noted by photograph on the purple housing inside of the threaded outflow graft attachment to the pump.The implant kit (b)(6) was determined to be defective and was sent back for evaluation.The system controller that came with the new implant kit was being returned with the defective implant kit.There was no reported patient impact.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the report of scratches within the purple housing was confirmed based on the evaluation of the returned outflow graft.The outflow graft, lot number 9117254, was returned in the implant kit suitcase.The graft was in the packaging tray; however, the seal and foil pouch were missing.Visual and microscopic inspection of the outflow graft was performed which revealed multiple scratches and impressions on the locking nut threads and the washer.The locking nut rotated easily when manipulated by hand.The outflow graft was engaged with the returned pump without issue.The scratches appeared to be cosmetic only and did not appear to contribute to any functional issues.The outflow graft was sent to (b)(4) under a manufacturing task.A blunt tool was used to feel the "scratch" and was found to be non-palpable.This area of the screw ring on the thread was also not blood-contacting and would only be a cosmetic issue with no impact on the functionality of the part.This part would have been acceptable in manufacturing as the "scratch" was less than the 0.25" length.Therefore, this complaint is not manufacturing or design-related and does not require any additional actions.The relevant sections of the device history records for outflow graft, lot number 9117254 were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate 3 left ventricle assist system (lvas) instructions for use (ifu), rev.C is currently available.Section 5 contains information on "preparing the sealed outflow graft" which states to examine the graft and to verify the black "o" ring and white washer are present and intact at the screw-ring end of the conduit.Inspect the interior of the graft and remove any debris.Section 5, ¿surgical procedures¿, 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: THORATEC® HEARTMATE 3¿
• 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: 19315666
• Report Number: 2916596-2024-02729
• Device Sequence Number: 3077337
• Product Code: DSQ
• UDI-Device Identifier: 00813024013266
• UDI-Public: (01)00813024013266(10)9117254(17)251025
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P160054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2024

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 Expiration Date: 10/25/2025
• Device Model Number: 105581US
• Device Catalogue Number: 105581US
• Device Lot Number: 9117254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2024
• 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: 04/26/2024
• Supplement Date Received by Manufacturer: 07/29/2024
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 08/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2023
• 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 Age: 32 YR
• Patient Sex: Male
• Patient Weight: 56 KG