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U.S. Department of Health and Human Services

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

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DATASCOPE FAIRFIELD SENSATION PLUS 8FR. 50CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0575
Device Problems Failure to Calibrate (2440); Device Displays Incorrect Message (2591)
Patient Problems Death (1802); Cardiogenic Shock (2262)
Event Date 12/20/2017
Event Type  Death  
Manufacturer Narrative
Death date changed from: (b)(6) 2017 to: (b)(6) 2017. Device evaluation: the product was returned with the membrane completely unfolded and blood on the exterior of the catheter and between the catheter and the sheath. The returned sheath was over the catheter. An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected. A sensor output test was performed and the sensor was found to be within specification. Two kinks were found on the catheter tubing approximately 43. 7cm and 74. 9cm from iab tip. The reported alarm, unable to calibrate sensor event cannot be confirmed by the evaluation. The product performed according to specification. A device and lot history record review was completed for the reported product. No non-conformances were found that are considered to be related to the event. Complaint # (b)(4), record # (b)(4).
 
Event Description
It was reported that upon initiation of intra-aortic balloon (iab) therapy the console was ¿unable to calibrate¿. Patient was brought to the procedure room for a cardiac catheterization due to non-st-elevation myocardial infarction (nstemi). Patient had left main disease and went into cardiogenic shock; two vasopressors were started and blood pressure was still not reading. Iab pump machine turned on and read "system failure" as catheter was connected. Patient was defibrillated and the console was replaced, however the procedure was still unsuccessful. Pressure monitor was switched to ecg to monitor pressures. The iab was removed. The patient expired five days after therapy, but the facility does not attribute the death to the device.
 
Manufacturer Narrative
The product has been returned to the manufacturer, but is pending investigation. Once the investigation is completed a supplemental report with our findings will be submitted. Complaint # (b)(4).
 
Event Description
It was reported that upon initiation of intra-aortic balloon (iab) therapy the console was ¿unable to calibrate¿. Patient was brought to the procedure room for a cardiac catheterization due to non-st-elevation myocardial infarction (nstemi). Patient had left main disease and went into cardiogenic shock; two vasopressors were started and blood pressure was still not reading. Iab pump machine turned on and read "system failure" as catheter was connected. Patient was defibrillated and the console was replaced, however the procedure was still unsuccessful. Pressure monitor was switched to ecg to monitor pressures. The iab was removed. The patient expired five days after therapy, but the facility does not attribute the death to the device.
 
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Brand NameSENSATION PLUS 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 Key7199085
MDR Text Key106170843
Report Number2248146-2018-00027
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112327
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/17/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/25/2020
Device Catalogue Number0684-00-0575
Device Lot Number3000060747
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer12/28/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received02/02/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/25/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 01/17/2018 Patient Sequence Number: 1
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