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

Model Number 106525US

Device Problem Mechanical Problem (1384)

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

Event Date 12/06/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of a driveline power fault was confirmed via log file analysis.A review of the downloaded log file from the submitted heartmate 3 system controller (serial number: (b)(4)).Contained events spanning approximately 4 days ((b)(6) 2021 per timestamp).Events occurring on (b)(6) 2021 were recorded during testing at abbott.Intermittent driveline power fault alarms were active throughout the log file.The driveline was disconnected on (b)(6) 2021 at 12:57:08 for a system controller exchange.There were no other alarms active in the log file.The returned modular cable (lot number: 7327184) was functionally tested.No alarms activated when the cable was connected to a mock loop and test controller.Additionally, the mod cable was connected to the returned system controller and allowed to run overnight.No alarms activated during this extended period.The resistances were measured and all underlying wires within the cable met the accepted resistance threshold.The insulation of the underlying wires was then tested.It was found that when manipulated, near the strain relief of the inline connector, the brown (power a) and black (ground) wires were found to have current leakage.An intermittent short between the brown and black wires, due to current leakage from these wires would cause a driveline power fault.The cable was stripped to look for any breaches in the conductor¿s coatings.No breaches were able to be found.The cause for the driveline power faults was due to damage to the driveline¿s underlying wires; however, a root cause for the damage was unable to be conclusively determined through this investigation.The device history records were reviewed and the records revealed the heartmate 3 vad modular cable (lot number: 7327184) was manufactured in accordance with manufacturing and qa specifications.Heartmate 3 patient handbook, alarms and troubleshooting¿ and heartmate 3 instructions for use (ifu), alarms and troubleshooting cover all alarms (visual and audible), including the driveline power fault alarm conditions, and the actions to take if the alarms cannot be resolved.Heartmate 3 instructions for use (ifu) "surgical procedures" cautions the user that sharp bends, twists, or kinks in the driveline may make it more susceptible to wear and fatigue over time."patient care and management" cautions the user to avoid pulling on or moving the driveline.This section further cautions: "do not twist, kink, or sharply bend the driveline, system controller power cables, the power module patient cable, or the mobile power unit patient cable, which may cause damage to the wires inside, even if external damage is not visible.Damage to the driveline or cables could cause the left ventricular assist device to stop.If the driveline or cables become twisted, kinked, or bent, carefully unravel and straighten." (under "caring for the driveline") instructs the user to check the driveline daily for signs of damage, such as cuts, holes, or tears."alarms and troubleshooting" provides additional instructions regarding driveline care in a sub-section entitled "what not to do: driveline and cables." "equipment storage and care" (under "cleaning the driveline") states, "as needed, clean exterior surfaces of the driveline cables with a damp, lint-free cloth.If more aggressive cleaning is needed, use warm water and mild dish soap." heartmate 3 lvas patient handbook section 4 "living with the heartmate 3" (under "caring for the driveline") contains information regarding how to clean and care for the driveline.This section instructs the user: "check the driveline daily for signs of damage (cuts, holes, tears).Call your hospital contact right away if the driveline is damaged (or might be damaged)." and "keep your driveline clean.Wipe off any dirt or grime.If the driveline gets dirty, use a towel with mild dish soap and warm water to gently clean it.Never submerge the driveline or other system components in water or liquid." in addition, section 5 "alarms and troubleshooting" contains a sub-section entitled "what not to do: driveline and cables", which explicitly cautions the user not to twist.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.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that the patient had a driveline power fault.The system controller and modular cable were exchanged, after which the alarm cleared.The log file confirmed the alarm cleared.

Manufacturer Narrative

G3 correction.Incorrect date was provided in section g3 of the previous report.The correct date was dec 6, 2021.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 (ASSISST) 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: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 13121598
• MDR Text Key: 287008668
• Report Number: 2916596-2021-07829
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013181
• UDI-Public: 00813024013181
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/10/2023
• Device Model Number: 106525US
• Device Catalogue Number: 106525US
• Device Lot Number: 7327184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2020
• 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 Age: 24 YR
• Patient Sex: Female
• Patient Weight: 109 KG
• Patient Race: Black Or African American