MAUDE Adverse Event Report: THORATEC CORP. ABBOTT HEARTMATE 2

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/10/2017

Event Type  Injury  

Event Description

Lvad explant, driveline covered with sterile glove tip, per the manufacturer's guidelines, glove tip dislodged and was retained in the abdomen.

• Brand Name: ABBOTT HEARTMATE 2
• Type of Device: HEARTMATE 2
• Manufacturer (Section D): THORATEC CORP.
• MDR Report Key: 7137368
• MDR Text Key: 95494636
• Report Number: MW5074123
• 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: 12/18/2017

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
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/19/2017
• 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 Outcome(s): Other
• Patient Age: 60 YR
• Patient Weight: 105