MAUDE Adverse Event Report: ABIOMED INC. IMPELLA CP

Model Number 0048-000

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 05/17/2017

Event Type  Injury  

Event Description

Impella catheter failed during an acute stemi procedure.The catheter functioned properly for 1 hour before an apparent malfunction.When the malfunction occurred, the patient's condition deteriorated quickly requiring intubation and cpr until the impella cp catheter and console could be exchanged for a new impella cp catheter and impella console.The second catheter and console functioned properly and the case was completed without further complications.Impella pump intermittently shut off and turned on, on its own, before complete malfunction.Representative was notified of equipment symptoms prior to failure.

• Brand Name: IMPELLA CP
• Type of Device: IMPELLA CP
• Manufacturer (Section D): ABIOMED INC.
• MDR Report Key: 6585550
• MDR Text Key: 75852830
• Report Number: MW5069951
• Device Sequence Number: 1
• Product Code: PBL
• 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: 05/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 0048-000
• Device Lot Number: 123319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2017
• 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): Life Threatening
• Patient Age: 82 YR