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

Model Number 106525US

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/13/2024

Event Type  malfunction  

Event Description

It was reported that the patient's modular cable was exchanged.

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.

Manufacturer Narrative

Manufacturer's investigation conclusion: review of the submitted image confirmed damage to the outer jacket of the patient¿s modular cable.Discoloration of the outer jacket and controller connector bend relief was also observed.Although a specific cause for the observed damage and discoloration could not be conclusively determined through this evaluation, it did not appear to contribute to an electrical issue.The account¿s submitted image revealed a tear in the outer jacket of the modular cable.The underlying armor layer was exposed but appeared to be intact, and there were no wires visible in this location.The damage appeared to be cosmetic only.Additionally, a tan discoloration was observed in the outer jacket, and a dark brown discoloration was observed in the controller connector bend relief.It was communicated that the modular cable will not be returned for evaluation.The patient remains ongoing on left ventricular assist system (lvas) support with no further reported issues reported at this time.The relevant sections of the device history record for the modular cable, lot number 7802060, were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate 3 instructions for use (ifu), rev.C, and heartmate 3 patient handbook, rev.D, are currently available.The patient handbook cautions the 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 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 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.

• Brand Name: HEARTMATE 3 VAD MODULAR CABLE
• Type of Device: 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: 18851883
• MDR Text Key: 337152155
• Report Number: 2916596-2024-01144
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013181
• UDI-Public: 00813024013181
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/20/2024
• Device Model Number: 106525US
• Device Lot Number: 7802060
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 71 KG