MAUDE Adverse Event Report: ST. JUDE MEDICAL HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE LVAD; VENTRICULAR (ASSIST) BYPASS

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/09/2017

Event Type  malfunction  

Event Description

The patient had a vad, heartmate 2 exchanged with a heartmate 3.The drivelines of the heartmate 2 were cut and covered with a single finger tip of a rubber sterile glove and sutured to the driveline which is considered non sterile wires.During the removal the driveline the rubber sterile finger broke off and remained in patient abdomen.The manufacturer should devise a safe product to cover the drivelines.

• Brand Name: HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE LVAD
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 7108650
• MDR Text Key: 94717924
• Report Number: MW5073917
• 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: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2017
• Is this an Adverse Event Report?: No
• 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 Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 105