MAUDE Adverse Event Report: THORATEC CORPORATION THORATEC® HEARTMATE II®, SYSTEM CONTROLLER; VENTRICULAR (ASSIST) BYPASS

Model Number	106762
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.
Event or Problem Description
It was reported that the patient had a controller exchange due to wear and tear on the controller.
Additional Manufacturer Narrative
Section d1: brand name: corrected section d4: model number, catalog number, and udi: corrected manufacturer¿s investigation conclusion: the reported event of damaged power cables on the hmii system controller (serial number: (b)(6) was confirmed via investigation of the returned controller.The submitted and downloaded log files were reviewed on the reported event date of 01apr2024 and showed the controller functioning as intended.The driveline was disconnected at 12:58 on (b)(6) 2024, consistent with the reported controller exchange.Upon initial observation of the returned controller, the damage to the power cable strain reliefs and jacket were noted.The controller passed functional testing with no issues or alarms.The power cables¿ wires were tested for raised resistances, and several were found to be higher than the accepted value on both cables, indicating wire fatigue.The power cables were stripped of their outer jackets and evidence of fluid ingress was found, but no external damage to the wires was noted or observed.Provided information indicated that the patient reported no adverse effects due to the controller exchange.The root cause of the reported event was not conclusively determined via this analysis.The device history records were reviewed revealed no deviations with manufacturing and qa specifications.The heartmate ii patient handbook (rev.G) instructs users to not twist, kink, or otherwise bend their system controller¿s power cords in a way that may damage them.The heartmate ii patient handbook (rev.G, section 10 ¿safety checklists¿) instructs users to regularly inspect their equipment for damage, including damage to the system controller¿s power cords, and to obtain replacements if needed.The heartmate ii patient handbook (rev.G, section titled "emergency contact list") cautions users to call their hospital contacts if they think, for any reason, any portion of their equipment is not functioning as usual, is broken, or they are uncomfortable with the operation of the equipment.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: THORATEC® HEARTMATE II®, SYSTEM CONTROLLER
• 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: 19165367
• Report Number: 2916596-2024-02435
• Device Sequence Number: 18097159
• Product Code: DSQ
• UDI-Device Identifier: 00813024013013
• UDI-Public: (01)00813024013013(17)241017
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P060040
• 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: Physician Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2024

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: Lay User/Patient
• Device Expiration Date: 10/17/2024
• Device Model Number: 106762
• Device Catalogue Number: 106762
• Device Lot Number: 8124066
• 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: 04/03/2024
• Supplement Date Received by Manufacturer: 09/23/2024
• Initial Report FDA Received Date: 04/23/2024
• Supplement Report FDA Received Date: 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2021
• 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 Age: 54 YR
• Patient Sex: Male
• Patient Weight: 119 KG