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	08/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of the gogear shower bag allowing fluid ingress inside was confirmed and reproduced.The gogear shower bag was returned in what appeared to be unremarkable physical condition.The bag was mounted in a sink, and water was poured onto the bag for approximately 15 minutes to induce a fluid ingress issue.The bag was then visually inspected.Fluid was observed at the base of the battery/battery clip enclosure.It appeared that the seams on the bottom of the bag had slightly loosened and allowed water to ingress slowly into the bag.The ingress was only observed at the bottom of the bag, and no fluid was noted inside of the top lid or within the controller pocket.A root cause for the reported fluid ingress was determined to be damaged seams on the bottom of the bag; however, a root cause for this damage could not be conclusively determined through this analysis.The relevant sections of the device history records for the heartmate gogear shower bag were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu) and the heartmate 3 lvas patient handbook are currently available.The current revisions of the ifu and patient handbook can be found on the eifu page of the abbott website.The ifu and patient handbook instruct the user to periodically inspect wear and carry accessories for damage or wear.These documents 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.The ifu further warns that the shower bag must dry completely between uses.After showering, the exterior of the bag should be wiped with a clean, dry towel, and the bag should be allowed to drip dry completely before being used again.No further information was provided.The manufacturer is closing the file on this event.
Event or Problem Description
It was reported that over the past six months, the patient experienced leaks in the shower bags when taking a shower.All zippers and clasps were secured.The patient was positive they were doing everything correct when putting the bag together and setting up the equipment.The equipment procedure was reviewed with the patient to ensure everything was correct.Batteries required drying after recent showers due to water exposure inside the shower bag.

• 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: 22907502
• Report Number: 2916596-2025-05348
• Device Sequence Number: 21104570
• Product Code: DSQ
• UDI-Device Identifier: 00813024011149
• UDI-Public: (01)00813024011149(10)10398848(11)240708
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/27/2025

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: 10398848
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2025
• 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: 08/06/2025
• Initial Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2024
• 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: 58 YR
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White