MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LVAD DRIVELINE; VENTRICULAR (ASSISST) BYPASS

Catalog Number 1225

Device Problem Output Problem (3005)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/08/2019

Event Type  malfunction  

Event Description

Patient came in for routine clinic appointment.It was found on vad interrogation that he had speed drops.Waveforms sent to abbott.Xrays taken.No visible deformity to drive line.Patient admitted and placed on ungrounded cable until the next day when abbott engineers could do a drive line repair.Drive line repair went without incident.Suspected portion of drive line that was removed was sent overnight to abbott for interrogation.Patient remained stable.

• Brand Name: HEARTMATE II LVAD DRIVELINE
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge dr; pleasanton CA 94588
• MDR Report Key: 9151048
• MDR Text Key: 161169076
• Report Number: 9151048
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/18/2019

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
• Device Operator: No Information
• Device Catalogue Number: 1225
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/18/2019
• Event Location: Other
• Date Report to Manufacturer: 10/03/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1