MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II; LEFT VENTRICULAR ASSIST DEVICE

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Date 04/03/2019

Event Type  Injury  

Event Description

On (b)(6) 2019 patient in clinic with noted tear to driveline.Rescue tape applied.

• Brand Name: HEARTMATE II
• Type of Device: LEFT VENTRICULAR ASSIST DEVICE
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 15105159
• MDR Text Key: 296651449
• Report Number: 15105159
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/21/2022
• Distributor Facility Aware Date: 06/08/2021
• Device Age: 3 YR
• Event Location: Home
• Date Report to Manufacturer: 07/21/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 79 KG