MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 TUNNELING LANCE AND HANDLE; DRIVELINE TUNNELER

Model Number	106533
Medical Device Problem Codes	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	12/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Approximate age of device ¿ 1 day.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) on (b)(6) 2018.It was reported that during the implant, the surgeon tunneled the driveline, but upon exiting the skin, 3 petals from the tunneling bullet were retained.All 3 petals of the tunneling bullet were retrieved.Reportedly, the surgeon had correctly moved the metal portion to cover the yellow line.
Additional Manufacturer Narrative
Device evaluation: the report of damage to the tunneling bullet could not be confirmed because the product was not returned for evaluation.The patient remains ongoing on heartmate 3 lvas, serial number (b)(4), and no further events 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 was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 TUNNELING LANCE AND HANDLE
• Common Device Name: DRIVELINE TUNNELER
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• MDR Report Key: 8224543
• Report Number: 2916596-2019-00026
• Device Sequence Number: 16200478
• Product Code: DSQ
• UDI-Device Identifier: 00813024013211
• UDI-Public: 00813024013211
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 106533
• Device Catalogue Number: 106533
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/18/2018
• Supplement Date Received by Manufacturer: 01/23/2019
• Initial Report FDA Received Date: 01/07/2019
• Supplement Report FDA Received Date: 02/12/2019
• 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: 39 YR
• Patient Weight: 122