MAUDE Adverse Event Report: ABIOMED ABIOMED; IMPELLA CATHETER

Device Problems Detachment Of Device Component (1104); Positioning Failure (1158)

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

Event Date 05/15/2017

Event Type  Injury  

Event Description

Part of impella catheter fell off while trying to deploy.

• Brand Name: ABIOMED
• Type of Device: IMPELLA CATHETER
• Manufacturer (Section D): ABIOMED; danvers MA 01923
• MDR Report Key: 6593560
• MDR Text Key: 76137960
• Report Number: MW5070023
• Device Sequence Number: 1
• Product Code: DQO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• 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 Outcome(s): Required Intervention
• Patient Age: 77 YR