MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE GOGEAR CONSOLIDATED BAG, LEFT; 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	01/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No further info was provided.A supplemental report will be reported once the manufacturer¿s investigation is completed.
Event or Problem Description
It was reported that a replacement was requested for an item under warranty.It was said the consolidated bag was faulty and leaking.The clips got wet due to the bag.A warranty request was requested for the shower bag for delivery on (b)(6) 2026.
Additional Manufacturer Narrative
Section a4: patient weight was requested but not provided.Manufacturer's investigation conclusion: the report of fluid ingress into the heartmate gogear shower bag could not be confirmed as the product was not returned for evaluation.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 10790318 were reviewed and showed no deviations from manufacturing or quality assurance specifications.The current revision of the instructions for use (ifu) can be found on the eifu page of the abbott website.The heartmate 3 lvas ifu, rev.D and the heartmate 3 lvas patient handbook, rev.D 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.
Event or Problem Description
It was said the shower bag was faulty and leaking.

• Brand Name: HEARTMATE GOGEAR CONSOLIDATED BAG, LEFT
• 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: fredric gold ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 24076895
• Report Number: 2916596-2026-00244
• Device Sequence Number: 9387976
• Product Code: DSQ
• UDI-Device Identifier: 00813024011149
• UDI-Public: (01)00813024011149(10)10790318(11)250418
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 02/02/2026

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: 10790318
• 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: 01/06/2026
• Supplement Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/18/2025
• 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: 54 YR
• Patient Sex: Female