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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE FAIRFIELD MEGA 8FR. 50CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE FAIRFIELD MEGA 8FR. 50CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0497
Device Problem Malposition of Device (2616)
Patient Problem Test Result (2695)
Event Date 01/09/2019
Event Type  Injury  
Manufacturer Narrative
The device was not returned and could not be evaluated. It was discarded by the user. We are unable to confirm the reported event. If new information becomes available, a supplemental report will be submitted. (b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy that the patient's lactate level began to increase. The iab's placement was checked, it was determined to be 10cm too low, and therefore was moved 5cm. A "check iab catheter" alarm was generated. Also there was poor augmentation and the iab was removed. The patient's lactate remained high after iab removal, but it was unattributed to the device by the facility.
 
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Brand NameMEGA 8FR. 50CC IAB
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer (Section G)
DATASCOPE FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer Contact
15 law drive
fairfield, NJ 07004
MDR Report Key8301769
MDR Text Key134931717
Report Number2248146-2019-00067
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K091449
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/22/2021
Device Catalogue Number0684-00-0497
Device Lot Number3000078918
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device Age YR
Event Location No Information
Date Manufacturer Received01/11/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/22/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage

Patient Treatment Data
Date Received: 02/04/2019 Patient Sequence Number: 1
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