MAUDE Adverse Event Report: INSIGHTRA MEDICAL, INC. ULTRA IAB CATHETER; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number IMU7F-35CC

Device Problems Fluid/Blood Leak (1250); Pumping Stopped (1503); Improper Flow or Infusion (2954)

Patient Problem Death (1802)

Event Date 08/14/2019

Event Type  Death  

Event Description

After cabg surgery, dr used ecmo and iabp to support pt at (b)(6) 2019.They found the cs300 alarm and stop pumping.They tried to restart pumping and found blood go in to catheter and stop pumping.Dr already took out the catheter from the pt.After coronary artery bypass grafting (cabg) surgery, the physician used extracorporeal membrane oxygenation (ecmo) and iabp to support the pt on (b)(6) 2019.During use of the iabp, an alarm was triggered and stopped pumping.They tried to restart pumping and found blood going into catheter and stopped the procedure.The physician removed the catheter from the pt and injected saline into the device which revealed a leakage (hole) at the end of the balloon.This pt was still treated using ecmo, but another iabp catheter to support pt with no issues.The pt died on (b)(6) 2019.Insightra was notified of pt's death on october 29, 2019.Pt (b)(6) y/o / male - console make and model: cs300.Pt vascular disease: calcification - catheter being used after cabg surgery.Incident occurred after 3 days of use.

• Brand Name: ULTRA IAB CATHETER
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): INSIGHTRA MEDICAL, INC. ; clarksville TN
• MDR Report Key: 9503852
• MDR Text Key: 172404175
• Report Number: MW5091779
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/15/2019

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: Health Professional
• Device Expiration Date: 11/01/2022
• Device Model Number: IMU7F-35CC
• Device Catalogue Number: D02-0001-102
• Device Lot Number: 11271702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/19/2019
• 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): Death; Hospitalization
• Patient Age: 45 YR