MAUDE Adverse Event Report: ABIOMED IMPELLA CP; TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP

Model Number IMPELLA CP

Device Problems Device Issue (2379); Material Deformation (2976); Positioning Problem (3009)

Patient Problem Blood Loss (2597)

Event Date 03/22/2018

Event Type  malfunction  

Manufacturer Narrative

The impella pump was returned for analysis.The wound closure tip was observed to be damaged.This confirms the reported failure and blood loss.In addition scratch mark were noted at the tip.A capa has been opened to address this failure.The failure mode will be monitored and trended.(b)(4).

Event Description

A (b)(6) year old male was admitted in cardiogenic shock and had an impella cp placed for hemodynamic support.While on impella support he had a coronary angioplasty and then when the team was preparing the patient for transport to the icu, they noticed they were unable to position the pump's repositioning sheath due to a split.The team had to reverse the anticoagulation, monitor the patient for his liter of blood lost, and place a femostop to the groin site.

• Brand Name: IMPELLA CP
• Type of Device: TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP
• Manufacturer (Section D): ABIOMED; 22 cherry hill drive; danvers MA 01923
• Manufacturer (Section G): ABIOMED; 22 cherry hill drive; danvers MA 01923
• Manufacturer Contact: ralph barisano ; 22 cherry hill drive; danvers, MA 01923 ; 9786461400
• MDR Report Key: 7400364
• MDR Text Key: 104809240
• Report Number: 1220648-2018-00023
• Device Sequence Number: 1
• Product Code: OZD
• UDI-Device Identifier: 00813502011258
• UDI-Public: 00813502011258
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 11/30/2019
• Device Model Number: IMPELLA CP
• Device Catalogue Number: 0048-0003
• Device Lot Number: 1318488
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR