MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 THREAD PROTECTORS SET

Model Number	1008821
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Doi not provided.No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.
Event or Problem Description
The patient was implanted with a left ventricular assist device (lvad).It was reported, that during procedure on (b)(6) 2018, the surgeon was passing the tunneller to pull driveline through the patient¿s body habitus, when a black segment of the tunneler adaptor broke off.The tunneling adapter will be returned for further evaluation.The pump was placed without issues and functioned as intended no further information was provided.
Additional Manufacturer Narrative
Section d4,h4: additional information: section d10, h3: corrected information: manufacturing evaluation conclusion: the report that the heartmate iii (hm3) tunneling adapter broke during the implantation of pump could not be confirmed through this investigation.The device was not returned for analysis.The patient remains ongoing on heartmate 3 lvas, and no additional complaints have been reported at this time.The hm3 lvas ifu describes how to attach the tunneling adapter and how to create the driveline exit site.This document also instructs the user to confirm that the yellow line on the tunneling adapter is fully covered for a secure connection.No further information is available.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 THREAD PROTECTORS SET
• Common Device Name: THREAD PROTECTOR
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• MDR Report Key: 7980976
• Report Number: 2916596-2018-04383
• Device Sequence Number: 13847719
• Product Code: DSQ
• UDI-Device Identifier: 00813024012993
• UDI-Public: 00813024012993
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P160054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2019

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 Expiration Date: 09/30/2020
• Device Model Number: 1008821
• Device Catalogue Number: 1008821
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/28/2018
• Supplement Date Received by Manufacturer: 12/19/2018
• Initial Report FDA Received Date: 10/18/2018
• Supplement Report FDA Received Date: 01/07/2019
• 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: 70 YR
• Patient Weight: 68