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	10/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the battery was wet due to leakage from the shower bag.When the battery was attempted to be charged, a red lamp would about about once a week.The shower bag and battery were exchanged.
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 e1: customer site was (b)(6).Manufacturer's investigation conclusion: the reported event of leakage from the shower bag was unable to be confirmed.The root cause of the reported event could not be conclusively determined through this investigation.The heartmate gogear shower bag (lot number 10220344) returned in unremarkable physical condition.The bag was mounted in the sink and water was poured onto it for an extended period of time to assess leakage to the internal compartments.The bag was then opened and inspected for signs of ingress, but none was found.The patient remains ongoing with heartmate system support with no further issues reported at this time.The relevant sections of the device history records for lot number 10220344 were reviewed and showed no deviations from manufacturing or quality assurance specifications.Heartmate 3 lvas ifu and the heartmate 3 patient handbook are currently available.The current revision of the instructions for use (ifu) can be found on the eifu page of the abbott website.Section 6 of the ifu, ¿patient care and management¿, and section 4 of the patient handbook, ¿living with the heartmate 3¿, provide instructions and images for how to properly put on, use, and take off the shower bag.This section provides instructions to ensure all components within the bag are protected from exposure to water.This section also instructs the user to not submerge the shower bag in water.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.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.¿ no further information was provided.The manufacturer is closing the file on this event.
Event or Problem Description
There was no indication that the bag was in inappropriate use at the time, and no damage to the shower bag was found.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

• 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: 23395921
• Report Number: 2916596-2025-06876
• Device Sequence Number: 10034512
• Product Code: DSQ
• UDI-Device Identifier: 00813024011149
• UDI-Public: (01)00813024011149(10)10220344(11)240309
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/18/2025

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: 10220344
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2025
• Supplement Date Received by Manufacturer: 10/28/2025; 12/16/2025
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 11/11/2025; 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2024
• 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: 18 YR
• Patient Sex: Male
• Patient Weight: 38 KG