MAUDE Adverse Event Report: THORATEC CORPORATION THORATEC® HEARTMATE® GOGEAR®, SHOWER BAG; VENTRICULAR (ASSIST) BYPASS

Model Number	104232
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2025
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 the patient dropped their equipment while in the shower in the shower bag.It was unknown if the shower bag appropriately closed at the time of the event the system controller got wet.Log files were submitted for review and did not capture any controller faults so there did not appear to be any immediate issues with the controller.
Additional Manufacturer Narrative
Section d4 (primary unique device identification (udi) number): correction section g4 (pma/510(k) #): correction.Manufacturer's investigation conclusion: a specific cause for the report of fluid ingress into the shower bag could not be conclusively determined through this evaluation.The relevant sections of the device history records for the shower bag, lot #9156292, were reviewed and showed no deviations from manufacturing or quality assurance specifications.Heartmate 3 left ventricular assist system (lvas) instructions for use (ifu) rev.C, and heartmate 3 lvas patient handbook rev.D, are currently available.Section 6 of the ifu ¿patient care and management¿ and section 4 of the patient handbook ¿living with the heartmate 3¿ explain how to the use the shower bag.These sections warn that the shower bag must be used for every shower.Although the external components of the heartmate 3 left ventricular assist system are moisture-resistant, they are not waterproof.Take care to protect external system components from water or moisture.Section 8 of the ifu "equipment storage and care" (under "cleaning heartmate wear and carry accessories") and section 6 of the patient handbook "caring for the equipment" (under "caring for the wear and carry accessories") state that wear and carry accessories should be periodically inspected for damage or wear.If an accessory appears damaged or worn, do not use it: call your hospital contact for a replacement.The current revisions of the instructions for use (ifu) and patient handbook can also be found on the electronic ifu (eifu) page of the abbott website.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: THORATEC® HEARTMATE® GOGEAR®, SHOWER BAG
• 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: 21463346
• Report Number: 2916596-2025-01054
• Device Sequence Number: 8750233
• Product Code: DSQ
• UDI-Device Identifier: 00813024011149
• UDI-Public: (01)00813024011149(10)9156292(11)230810
• Combination Product (Y/N): N
• Initial Reporter State: DC
• 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): 03/28/2025

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 Model Number: 104232
• Device Catalogue Number: 104232
• Device Lot Number: 9156292
• Was Device Available for Evaluation?: No
• 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: 02/07/2025
• Supplement Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/10/2023
• 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 Age: 59 YR
• Patient Sex: Female
• Patient Weight: 107 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American