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	08/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the metal carabiner broke off from the metal eyelet holder causing the carrying strap to become insufficient and the heartmate 3 system to fall off, resulting in tension at the driveline exit site and accompanying bleeding.The bag was replaced.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.
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 additionally reported that the patient had only micro bleedings due to small skin lesions around the exit site which were due to the tension of the driveline during the fall of the bag.The patient was treated with clotting dressings, and the patient was stable.
Additional Manufacturer Narrative
Section h5/h9: usage of device corrected.Manufacturer's investigation conclusion: the reported event of the gogear consolidated bag having a dislodged snaphook was confirmed, as the returned consolidated bag (lot number 9213649) was observed to have one of its snaphooks missing from its respective d-ring upon arrival.T the fitting hole of the shoulder strap d-ring was observed to be slightly worn 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 snaphook dislodging from its intended position.The connection of the other carabiner clip was unremarkable.The consolidated bag zippers, controller pocket buckle, and the shoulder strap connection of the side with the intact carabiner clip were tested and functioned as intended.A manufacturing analysis task was completed to address the reported event further.A supplier corrective action request (scar) was issued to notify the supplier of the reported event as a result of the manufacturing analysis task.The root cause of the reported event was determined to be supplier-related.Device history records was reviewed and showed no deviations from manufacturing or qa specifications.The current revision of the ifu can be found on the eifu page of the abbott website.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu), and 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: 22960135
• Report Number: 2916596-2025-05772
• Device Sequence Number: 18550677
• Product Code: DSQ
• UDI-Device Identifier: 00813024011279
• UDI-Public: (01)00813024011279(10)9213649
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/02/2025

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: 9213649
• 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: 08/28/2025
• Supplement Date Received by Manufacturer: 09/02/2025; 09/23/2025
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 09/17/2025; 10/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2023
• 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: 67 YR
• Patient Sex: Male