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	05/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that log files were sent for review because the patient stated that the battery(s) got wet when getting in the shower and then heard alarms when it happened.On the device, it was noted that there was a low voltage hazard instead of the typical low voltage advisory.The site wanted further assessment.Technical services (ts) reviewed the submitted log files and found that the patient had persistent pulsatility index (pi) events that had shortened the data capture to just several hours.Ts was unsure when the shower event happened, but it looked like it had been overwritten with new incoming data from the pi events.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.
Additional Manufacturer Narrative
Section e2 correction.Section e3 correction.Manufacturer's investigation conclusion: the report of fluid ingress into the heartmate gogear shower bag could not be confirmed through this evaluation.Multiple attempts were made to obtain additional information regarding the reported event; however, no further information was provided by the account.The patient remains ongoing on heartmate 3 left ventricular assist system (lvas) support with no further reported issues at this time.The lot number of the heartmate gogear shower bag was not provided.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu) and the heartmate 3 patient handbook 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 ifu and patient handbook can be found on the 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: 22186504
• Report Number: 2916596-2025-03558
• Device Sequence Number: 8506088
• Product Code: DSQ
• UDI-Device Identifier: 00813024011149
• UDI-Public: (01)00813024011149
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 07/11/2025

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
• 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: 05/22/2025
• Supplement Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 68 YR
• Patient Sex: Female
• Patient Weight: 60 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White