MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC LINEAR 7.5 FR IAB CATHETER; INTRA-AORTIC BALLOON CATHETER

Catalog Number 068400048001U

Device Problems Backflow (1064); Material Rupture (1546); Device Displays Incorrect Message (2591)

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

Event Date 12/20/2019

Event Type  Injury  

Event Description

Iabp alarmed and pump was checked.It was noted that blood was hacking up into the helium line.Balloon pump removed and noted to have ruptured.Fda safety report id# (b)(4).

• Brand Name: LINEAR 7.5 FR IAB CATHETER
• Type of Device: INTRA-AORTIC BALLOON CATHETER
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; fairfield NJ 07004
• MDR Report Key: 9569152
• MDR Text Key: 174499309
• Report Number: MW5092104
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/04/2020
• Device Catalogue Number: 068400048001U
• Device Lot Number: 3000063258
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/08/2020
• 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): Other; Required Intervention
• Patient Age: 88 YR