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	10/28/2025
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 water was getting into the shower bag.
Additional Manufacturer Narrative
D6a - date of implant was inadvertently added in the initial report and is not applicable for this product.Manufacturer's investigation conclusion: evaluation of the returned gogear shower bag could not confirm the reported event of fluid ingress.A specific cause for the reported event could not be conclusively determined through this evaluation.There was reportedly no damage to the bag, and there was no impact to the patient¿s controller or batteries.The shower bag was returned zipped in used condition.The shoulder strap was returned attached to the bag on both sides; the shoulder strap was unremarkable.No wear or damage was observed on the bag fabric, seams, zippers, or buckle.No evidence of fluid ingress was observed.The shower bag was mounted in a sink and water was poured onto the bag for an extended period of time.Following the test, the bag was inspected and revealed no evidence of fluid ingress.The bag¿s zippers, buckle, and clips functioned as intended.The patient remains ongoing on heartmate 3 left ventricular assist system support with no further related issues reported at this time.The lot number was not provided.This product is not serialized.The lot number is not printed on the product and is only available on the box/at the time the product is opened.This is not an out of box failure and the failure mode was not noticed at initial use.The heartmate 3 lvas ifu, and the heartmate 3 patient handbook, are currently available.The ifu and patient handbook instruct the user to periodically inspect the wear and carry accessories for damage or wear.These documents advise that if an accessory appears damaged or worn, the accessory should not be used.It is recommended that the manufacturer be contacted with questions or to order a replacement, if needed.The ifu explains that although the external components of the heartmate 3 lvas (including the shower bag) are moisture-resistant, they are not waterproof.The ifu warns that the shower bag must dry completely between uses.After showering, the exterior should be wiped with a clean, dry towel and the bag should be allowed to drip dry completely before being used again.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: 23458095
• Report Number: 2916596-2025-07145
• Device Sequence Number: 12780912
• Product Code: DSQ
• UDI-Device Identifier: 00813024011149
• UDI-Public: (01)00813024011149
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P160054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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
• Report Date (Section B): 12/23/2025

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
• 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: 10/28/2025
• Supplement Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 22 YR
• Patient Sex: Male
• Patient Weight: 78 KG