MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 VAD MODULAR CABLE; VENTRICULAR (ASSIST) BYPASS

Model Number	106525
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that modular cable was broken.The modular cable was exchanged.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported damage to the modular cable was confirmed through review of the submitted image; however, a specific cause for the observed damage could not be conclusively determined through this evaluation.The submitted image captured a tear in the patient¿s outer jacket.The armor layer at the location of the tear was exposed but appeared intact with no wires visible.Although a specific cause for the observed damage and discoloration could not be conclusively determined, it did not appear to have contributed to an electrical issue as no alarms were reported by the customer.Multiple attempts were made to obtain additional information regarding the reported event; however, no additional information has been provided by the account.The patient remains ongoing on left ventricular assist system (lvas) support with no further events 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 reported event and subsequent investigation do not indicate an issue with the manufacture of the product.The current revisions of the ifu and patient handbook can be found on the eifu page of the abbott website.The heartmate 3 lvas ifu, rev.C and the heartmate 3 lvas patient handbook, rev.B are currently available.The patient handbook cautions users to call their hospital contacts if they think, for any reason, any portion of their equipment is not functioning as usual, is broken, or they are uncomfortable with the operation of the equipment.Section 2 of the ifu, ¿system operations,¿ explains that if it has been determined that damage has been detected in the modular cable, it should be replaced and provides instructions on how to do so.The ifu and patient handbook contain information on how to clean and care for the driveline.Section 6 of the ifu and section 4 of the patient handbook instruct the user to keep the driveline clean and check the driveline daily for signs of damage, such as cuts, holes, or tears.The patient handbook also states, ¿call your hospital contact right away if the driveline is damaged (or might be damaged)." section 7 of the ifu and section 5 of the patient handbook provide additional instructions regarding driveline care in sub-sections entitled, "what not to do: driveline and cables.¿ furthermore, section 8 of the ifu and section 4 of the patient handbook instruct the user to clean exterior surfaces of the driveline cables with a damp, lint-free cloth and if more aggressive cleaning is needed, to use warm water and mild dish soap.No further information was provided.The manufacturer is closing the file on this event.
Event or Problem Description
It was additionally reported that the damage was on the outer layer of the modular cable only.No internal wire exposure was reported.

• Brand Name: HEARTMATE 3 VAD MODULAR CABLE
• 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: 23312640
• Report Number: 2916596-2025-06479
• Device Sequence Number: 5788829
• Product Code: DSQ
• UDI-Device Identifier: 05415067039385
• UDI-Public: (01)05415067039385
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Report Date (Section B): 12/15/2025

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: 106525
• Device Catalogue Number: 106525
• 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: 10/01/2025
• Supplement Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Male