MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE GOGEAR CONSOLIDATED BAG, LEFT; VENTRICULAR (ASSIST) BYPASS

Model Number	106449
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
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 the shoulder strap on the bag was defective and the snap hook came loose during carrying.The patient's carrying bag came loose at the connection point between the snap hook and the eyelet through which the snap hook was attached to the carrying strap.The loosening caused the bag to fall off creating greater tension on the driveline, which in turn led to bleeding at the driveline exit point.The bag was exchanged.
Additional Manufacturer Narrative
B3: event date updated.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the report of a dislodged snaphook was confirmed through evaluation of the returned bag.Component wear was confirmed that would have contributed to the event, and the reported event is also related to an identified vendor manufacturing issue.The customer submitted 2 photos for analysis.Both of the submitted photos showed the snaphook disconnected from the fitting hole of the respective d-ring.Some wear to the snaphook pin could be seen in the submitted photos.The consolidated bag was returned in used condition with the shoulder strap returned detached from the bag on one side.One of the snaphooks was returned dislodged from the fitting hole of the respective d-ring.Both the pin and the d-ring appeared heavily worn and misshapen, which appeared to be consistent with normal use wear.Wear of the d-ring over time appeared to result in material fatigue and misshaping of the hole, which could have contributed to the reports of the snaphook dislodging from its intended position.The reported event was able to be reproduced during testing by re-inserting the snaphook into the d-ring and removing it again with minimal effort.The connection of the other snaphook was not able to be disengaged during testing.Supplier corrective action request (scar) was sent to the supplier regarding issues with the snaphook component.The relevant sections of the device history records for consolidated bag, lot number 10344306 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 left ventricle assist system (lvas) instructions for use (ifu) and the heartmate 3 patient handbook are currently available.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 consolidated bag.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.¿ no further information was provided.The manufacturer is closing the file on this event.

• 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 23501171
• Report Number: 2916596-2025-06884
• Device Sequence Number: 9116020
• Product Code: DSQ
• UDI-Device Identifier: 05415067039927
• UDI-Public: (01)05415067039927(10)10344306(11)240522
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/16/2025

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: 106449
• Device Catalogue Number: 106449
• Device Lot Number: 10344306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 10/14/2025
• Supplement Date Received by Manufacturer: 11/07/2025; 12/02/2025
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 11/20/2025; 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Female