MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II UNSHIELDED 14V PATIENT CABLE; VENTRICULAR (ASSISST) BYPASS

Model Number	10002010
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.
Event or Problem Description
It was reported that the pins on the inside of ungrounded patient cable broke.Patient was placed on batteries.No further information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of broken pins inside the unshielded patient cable was not confirmed as the patient cable was not returned for evaluation.Multiple requests for additional information were made to determine if the patient cable would be returned for evaluation; however, no response was received.The root cause of the reported event could not be conclusively determined through this analysis.The reported event and subsequent investigation do not indicate an issue with the manufacture of the product.Heartmate ii patient handbook section 3 ¿powering the system¿ provides information about the various ways to power the heartmate ii lvas, including how to use the power module and how to power module patient cable to a system controller.This section states ¿when connecting power cable connectors, do not try to join them together without first aligning the half circles inside the connectors.Joining together misaligned power cable connectors may damage them.¿ heartmate ii patient handbook section 10 ¿safety checklists¿ provides checklists to assist the patient in performing routine maintenance of the heartmate ii lvad, including inspecting the power module patient cable connector pins and sockets for dirt, grease, or damage.Heartmate ii patient handbook and heartmate ii instructions for use (ifu) caution 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.

• Brand Name: HEARTMATE II UNSHIELDED 14V PATIENT CABLE
• Common Device Name: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• MDR Report Key: 9794176
• Report Number: 2916596-2020-00888
• Device Sequence Number: 14007157
• Product Code: DSQ
• UDI-Device Identifier: 00813024011903
• UDI-Public: 00813024011903
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P060040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/11/2020

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: 10002010
• Device Catalogue Number: 10002010
• Device Lot Number: 6727916
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/13/2020
• Supplement Date Received by Manufacturer: 03/18/2020; 05/08/2020
• Initial Report FDA Received Date: 03/05/2020
• Supplement Report FDA Received Date: 03/23/2020; 05/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Weight: 91