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	11/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that water had started to penetrate the shower bag from the bottom.The bag was discarded.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported damage to the patient's shower bag was unable to be confirmed as no images were provided and the device was not returned for evaluation.The patient remains ongoing on heartmate 3 left ventricular assist system (lvas) support with no further related issues reported at this time.The relevant sections of the device history records for the heartmate gogear shower bag, lot number 8985644, were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu) rev.A, and the heartmate 3 lvas patient handbook rev.C, are currently available.The current revisions of the ifu and patient handbook can be found on the electronic ifu (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.

• 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: 23621913
• Report Number: 2916596-2025-07453
• Device Sequence Number: 18410203
• Product Code: DSQ
• UDI-Device Identifier: 00813024011149
• UDI-Public: (01)00813024011149(10)8985644(11)230414
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/21/2025

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: 8985644
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2025
• Initial Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/14/2023
• 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: 33 YR
• Patient Sex: Female
• Patient Weight: 49 KG