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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION 7FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - FAIRFIELD SENSATION 7FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0684-00-0470-01
Device Problems Filling Problem (1233); Off-Label Use (1494)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/11/2021
Event Type  malfunction  
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. Complaint record id # (b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy, the console repeatedly indicated that there was an auto-fill failure and was unable to resume pumping. The customer had tried two consoles and experienced the same issue. The insertion was reported to be axillary, which is not the method described in the device instructions for use. The customer was made aware of the off-label use. They then attempted pressing the fill key, but that was not successful. There were no visible kinks in the iab and no blood seen in the helium tubing. It was also confirmed that there was helium displayed in the tank. Due to the inability to restart pumping, the customer was then advised to consider removal/ replacement of the iab. There was no patient harm or adverse event reported.
 
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Brand NameSENSATION 7FR. 40CC IAB
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ
Manufacturer (Section G)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ
Manufacturer Contact
dorota wolpiuk
15 law drive
fairfield, NJ 
MDR Report Key11922772
MDR Text Key253809238
Report Number2248146-2021-00348
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K063525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0684-00-0470-01
Device Catalogue Number0684-00-0434
Device Lot Number3000134828
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/16/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/20/2020
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: 06/02/2021 Patient Sequence Number: 1
Treatment
UNKNOWN.
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