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	12/03/2024
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 the patient's shower bag filled with water while they were showering, despite the customer reporting that the shower bag had been used correctly by the patient.The system controller was wet but received the least amount of water due to being at the top of the shower bag.The batteries and battery clips at the bottom of the shower bag were submerged in water.Multiple audible alarms were heard by the patient, which resolved after they dried the equipment, but no alarms were found during their clinic visit, and no further alarms were heard.The patient was asymptomatic throughout the entire event, and no changes were made to the controller.There was no damage to any of the equipment.Event log files were submitted for review and captured routine events despite the water exposure.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the report of fluid ingress into the heartmate gogear shower bag could not be confirmed through this evaluation as the product was not returned for evaluation.Log files were submitted for review and captured routine events.The patient remains ongoing on heartmate 3 left ventricular assist system (lvas) support with no further reported events at this time.The relevant sections of the device history records for the gogear shower bag, lot number 8318642 were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate 3 lvas instructions for use (ifu) and the heartmate 3 patient handbook are currently available.Section 8 of the ifu, ¿equipment storage and care¿, and section 6 of the patient handbook, ¿equipment maintenance¿, instruct the user to periodically inspect the wear and carry accessories for damage or wear.These sections further state ¿if an accessory appears damaged or worn, do not use it.Contact the manufacturer with questions or to order a replacement, if needed¿.The ifu and patient handbook also provide instructions on using and assembling the shower bag.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: 20919264
• Report Number: 2916596-2024-52459
• Device Sequence Number: 15551281
• Product Code: DSQ
• UDI-Device Identifier: 00813024011149
• UDI-Public: (01)00813024011149(10)8318642(11)220502
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 02/20/2025

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: 8318642
• 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: 12/03/2024
• Supplement Date Received by Manufacturer: 02/19/2025
• Initial Report FDA Received Date: 12/12/2024
• Supplement Report FDA Received Date: 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/05/2022
• 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: 50 YR
• Patient Sex: Male
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American