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U.S. Department of Health and Human Services

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

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DATASCOPE FAIRFIELD SENSATION 7FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0434
Device Problem Device Contamination with Body Fluid (2317)
Patient Problems Death (1802); Myocardial Infarction (1969)
Event Date 08/06/2016
Event Type  Death  
Manufacturer Narrative
Correction: date was not entered in the initial mdr. Date: (b)(6) 2016.
 
Event Description
The patient arrived with a stemi of the rca and in an effort to stabilize her the physician used an iab catheter. The staff noticed blood in the tubing and it was removed, another iab was not inserted. After removal the patient remained stable however later that night she had another mi and expired.
 
Manufacturer Narrative
It is confirmed that the device was discarded and will not be returning to the manufacturer, we are unable to complete an evaluation on the affected product. If additional information is provided we will send a supplemental report with additional findings. (b)(4).
 
Event Description
The patient arrived with a stemi of the rca and in an effort to stabilize her the physician used an iab catheter. The staff noticed blood in the tubing and it was removed, another iab was not inserted. After removal the patient remained stable however later that night she had another mi and expired.
 
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Brand NameSENSATION 7FR. 40CC IAB
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key5905064
MDR Text Key106069578
Report Number2248146-2016-00068
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,consum
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/25/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0684-00-0434
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received08/10/2016
Was Device Evaluated by Manufacturer? No Answer Provided
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: 08/25/2016 Patient Sequence Number: 1
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