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

Model Number IMPELLA CP

Device Problems Difficult to Insert (1316); Kinked (1339)

Patient Problem Blood Loss (2597)

Event Date 06/07/2018

Event Type  malfunction  

Manufacturer Narrative

The impella pump product was returned for evaluation and analysis.The clinical account from the physician indicates that the outflow cage was positioned outside the body while attempting to insert a new guidewire to regain access.This allows a clear path for bleeding from the site, resulting in the loss of one unit of blood via the positioning of the outflow cage outside of the body during attempted rewiring.No corrective action is warranted and the failure mode will be monitored and trended.

Event Description

A patient post-operative from a amplatz plug placement for embolization, had an impella cp placed via the right femoral artery.Shortly after placement, the pump came out of position in the left ventricle.During re-positioning attempts the cannula of the pump kinked.The team attempted to re-wire and remove the kinked pump.During these attempts the patient lost blood and had one unit of blood replacement.The team was unable to access again via the right femoral artery, and instead placed the impella in the left femoral and support was successful.Support was successful for over 244 hours.

• 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: 7652753
• MDR Text Key: 112891853
• Report Number: 1220648-2018-00069
• Device Sequence Number: 1
• Product Code: OZD
• 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: 06/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 02/29/2020
• Device Model Number: IMPELLA CP
• Device Catalogue Number: 0048-0026
• Device Lot Number: 1330432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2018
• 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: 73 YR