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U.S. Department of Health and Human Services

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

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MAQUET CARDIOVASCULAR LLC LINEAR 7.5 FR IAB CATHETER INTRA-AORTIC BALLOON CATHETER Back to Search Results
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).
 
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Brand NameLINEAR 7.5 FR IAB CATHETER
Type of DeviceINTRA-AORTIC BALLOON CATHETER
Manufacturer (Section D)
MAQUET CARDIOVASCULAR LLC
fairfield NJ 07004
MDR Report Key9569152
MDR Text Key174499309
Report NumberMW5092104
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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
Date FDA Received01/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/04/2020
Device Catalogue Number068400048001U
Device Lot Number3000063258
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 01/08/2020 Patient Sequence Number: 1
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