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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD LINEAR 7.5 FR. 34CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - FAIRFIELD LINEAR 7.5 FR. 34CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0474
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Death (1802)
Event Date 06/21/2019
Event Type  Death  
Manufacturer Narrative
The device has not been returned to the manufacturer so we are unable to complete an evaluation. If provided we will send a supplemental report with our additional findings. (b)(4).
 
Event Description
Reported via medsun # (b)(4) received by getinge on 7/29/2019: the patient was transferred from the intensive care unit to the cath lab for impella placement with intra-aortic balloon (iab) catheter in place and the console was being used on battery. Upon arrival to the cath lab, the iab console shut off. The console was immediately plugged into an outlet and the device came on but was not functioning properly. The staff was unable to palpate pulses and cardiopulmonary resuscitation was initiated. The patient was initially admitted in cardiogenic shock, status post st elevation myocardial infarction and underwent a mitral valve replacement and coronary artery bypass grafting x3. Post-operatively, the patient was on multiple vasoactive infusions and was extremely unstable. The impella device was successfully placed the same day, but was reported to be a last ditch effort. The patient expired the next day, post-operatively day 4. The facility reported that the iab console failure was not believed to be a contributing factor in the patient's death. This report is for the iab catheter, for which there was no reported malfunction.
 
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Brand NameLINEAR 7.5 FR. 34CC IAB
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer (Section G)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer Contact
15 law drive
fairfield, NJ 07004
MDR Report Key8914994
MDR Text Key155028584
Report Number2248146-2019-00703
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K041281
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Risk Manager
Type of Report Initial,Followup
Report Date 08/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/21/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number0684-00-0474
Device Lot NumberASKU
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received08/28/2019
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/21/2019 Patient Sequence Number: 1
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