MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE SYSTEM MONITOR TO POWER MODULE CABLE; VENTRICULAR (ASSIST) BYPASS

Model Number	103859
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of damage to the system monitor to power module cable was confirmed.The system monitor to power module cable (lot number: 25656) was not returned for analysis; however, an image was submitted for review.A review of the image showed damage near the connector.The cable had been pulled out of the strain relief, exposing the shielding and underlying wires.Provided information stated that the cord was discarded by the center and therefore will not be returning for evaluation.A root cause for the damage was unable to be conclusively determined through this investigation.The device history records for the heartmate system monitor to power module cable were unable to be reviewed due to the records being unavailable.The heartmate 3 instructions for use section 4 entitled ¿system monitor¿) provides instruction on how to properly install and uninstall the system monitor data cable.The heartmate 3 instructions for use section 8 entitled ¿equipment storage and care¿) describes how to properly store, transport, and clean all heartmate equipment.The heartmate 3 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.No further information was provided.The manufacturer is closing the file on this event.
Event or Problem Description
It was reported that a system monitor cable was noted to be damaged at the end attached to the system monitor.The cable had exposed electrical wires.

• Brand Name: HEARTMATE SYSTEM MONITOR TO POWER MODULE 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: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 15428751
• Report Number: 2916596-2022-13885
• Device Sequence Number: 4621804
• Product Code: DSQ
• UDI-Device Identifier: 00813024010753
• UDI-Public: 00813024010753
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/15/2022

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: Health Professional
• Device Model Number: 103859
• Device Catalogue Number: 103859
• Device Lot Number: 25656
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2022
• Initial Report FDA Received Date: 09/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown