MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE TOUCH KIT; VENTRICULAR (ASSIST) BYPASS

Model Number HMT1100

Device Problems Improper or Incorrect Procedure or Method (2017); Data Problem (3196)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/04/2024

Event Type  malfunction  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.

Event Description

It was reported that the clinician noticed some unknown gaps in data and log files were submitted for review.Related manufacturer reference number: 2916596-2024-01477 (heartmate 3 lvas).Related manufacturer reference number: 2916596-2024-01577 (system controller).

• Brand Name: HEARTMATE TOUCH KIT
• Type of Device: 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: 18961932
• MDR Text Key: 338498152
• Report Number: 2916596-2024-01483
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 05415067032058
• UDI-Public: 05415067032058
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HMT1100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 24 YR
• Patient Sex: Male
• Patient Weight: 69 KG