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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSIGHTRA MEDICAL, INC. ULTRA IABP CATHETER KIT INTRA AORTIC BALLOON CATHETER

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INSIGHTRA MEDICAL, INC. ULTRA IABP CATHETER KIT INTRA AORTIC BALLOON CATHETER Back to Search Results
Model Number IMUF7-35
Device Problem Gas Leak (2946)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/11/2016
Event Type  malfunction  
Manufacturer Narrative
Not returned to manufacturer.
 
Event Description
A distributor reported that a customer experienced gas leak alarms on an arrow autocat 2 wave console approximately one day post open-heart surgery. Based on the report, the iab was functioning properly while the patient was in the operating theater and the gas alarms triggered after the patient had been transferred to the icu. The helium gas pressure began dropping, followed by a failure to inflate the balloon. The on-site nurse identified a leak at the y-connector of the iab catheter. There was no reported patient harm.
 
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Brand NameULTRA IABP CATHETER KIT
Type of DeviceINTRA AORTIC BALLOON CATHETER
Manufacturer (Section D)
INSIGHTRA MEDICAL, INC.
9200 irvine center drice
suite 200
irvine CA 92618
Manufacturer (Section G)
INSIGHTRA MEDICAL, INC.
9200 irvine center drive
suite 200
irvine CA 92618
Manufacturer Contact
thomas colonna
9200 irvine center drive
suite 200
irvine, CA 92618
9492151835
MDR Report Key5923620
MDR Text Key54461124
Report Number2032677-2016-00009
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeSN
PMA/PMN Number
K082746
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/01/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/01/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/01/2020
Device Model NumberIMUF7-35
Device Catalogue NumberIMUF7-35
Device Lot Number12071502
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/12/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/07/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/01/2016 Patient Sequence Number: 1
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