MAUDE Adverse Event Report: UNKNOWN; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)

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

Event Date 07/03/2019

Event Type  malfunction  

Event Description

During implant of heartmate 3 lvad, black part of driveline bullet tip separated from device.Surgeons aware and attempted of foreign object using scope, visual inspection, and c-arm x-ray to visualize.Foreign object could not be found in pt.No injury to pt.Supply vendor contacted.Fda safety report id# (b)(4).

• Brand Name: UNKNOWN
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• MDR Report Key: 8794549
• MDR Text Key: 151457981
• Report Number: MW5088171
• Device Sequence Number: 3
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/11/2019
• 3 Devices were Involved in the Event: 1 2 3

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/15/2019
• 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: 64 YR