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	07/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no patient involved in this event.The pma# provided is associated with most recent approval.A supplemental report will be submitted once the manufacturer¿s investigation is completed.Initial reporter phone number: (b)(6).
Event or Problem Description
It was reported that the system monitor to power module cable was damaged and the wires were exposed next to the connector.The system monitor was still fully functional, but the hospital wished to exchange the system monitor to prevent further technical issues.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of damage to heartmate system monitor to power module cable was confirmed via review of the submitted photo.This photo revealed that the cable had slightly pulled out of its strain relief at one end, exposing its inner wires and shielding.No damages to the inner wires were conclusively observed, and no functional issues regarding the cable were reported.The cable was not returned for evaluation, and the root cause of the reported event was unable to be conclusively determined via this analysis.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 system monitor instructions for use inform the user to refer any servicing of heartmate lvas equipment to trained service personnel only.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.The device history records for the system monitor data cable were unable to be reviewed, as they reside with the original equipment manufacturer (oem).The lot number of the cable was also not provided.The manufacturer is closing the file on this event.

• 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: 15203655
• Report Number: 2916596-2022-12863
• Device Sequence Number: 14632028
• Product Code: DSQ
• UDI-Device Identifier: 00813024010753
• UDI-Public: 813024010753
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 10/07/2022

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
• 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: 07/18/2022
• Supplement Date Received by Manufacturer: 10/04/2022
• Initial Report FDA Received Date: 08/10/2022
• Supplement Report FDA Received Date: 10/07/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown