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

Model Number	106449
Medical Device Problem Codes	Material Split, Cut or Torn (4008); Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a consolidated bag was completely unusable and the patient was in high need of a replacement.The part that connects the strap to the bag broke and caused the system controller to hit the floor and that tugged on their driveline.It also would not stay zipped.No troubleshooting was attempted and nothing was replaced by the clinic.The product will return.
Additional Manufacturer Narrative
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 reported damage to the strap and zipper of the consolidated bag could not be confirmed.The patient remains ongoing on heartmate 3 left ventricular assist system (lvas) support with no further issues reported at this time.The device history record for the gogear consolidated bag, lot number 10025585 was reviewed and showed no deviations from manufacturing or qa specifications.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu), rev.C, and the heartmate 3 patient handbook rev.D, 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.
Event or Problem Description
Additional information provided that dme sent a replaced bag.The patient had not returned the bag and was seen in clinic on(b)(6) with no issues reported.

• 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: 20837879
• Report Number: 2916596-2024-07631
• Device Sequence Number: 3759396
• Product Code: DSQ
• UDI-Device Identifier: 00813024011279
• UDI-Public: (01)00813024011279(10)10025585
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2025

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: 10025585
• Was Device Available for Evaluation?: No
• 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: 11/14/2024
• Supplement Date Received by Manufacturer: 01/03/2025
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 01/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/19/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White