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	01/04/2026
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 seeped into the shower bag from the bottom.Even when it was covered with gauze, water still seeped in.There was no health hazard to the patient.
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 unknown if there was any other equipment damaged due to fluid ingress.
Additional Manufacturer Narrative
Section d4: device serial number and lot number were not provided, and expiration date and manufacture date (h4) cannot be determined.The primary udi number in d4 is reflective of all available information.Manufacturer's investigation conclusion: evidence of water ingress was confirmed through the evaluation of the returned shower bag.The external portion of the bag did not reveal any damage or wear to any of the seams, zippers, or fabrics that could have contributed to a potential leak.Visual inspection of the interior of the bag revealed no evidence of water ingress.The bag was mounted in a sink and sprayed directly with water.Following the test, evidence of water was observed inside the bag, and the interior surfaces felt wet to the touch.The cause of the water ingress could not be conclusively determined.It was unknown if their equipment was damaged because of fluid ingress.The patient remains ongoing on left ventricular assist system support with no further related issues reported at this time.The current revision of the ifu and patient handbook can be found on the eifu page of the abbott website.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 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.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.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: fredric gold ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 24052237
• Report Number: 2916596-2026-00110
• Device Sequence Number: 15819020
• Product Code: DSQ
• UDI-Device Identifier: 05415067038173
• UDI-Public: (01)05415067038173
• 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): 02/23/2026

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
• 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: 01/05/2026
• Supplement Date Received by Manufacturer: 01/28/2026; 02/20/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 02/13/2026; 02/23/2026
• 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: 55 YR
• Patient Sex: Male
• Patient Weight: 55 KG