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U.S. Department of Health and Human Services

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

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DATASCOPE CORP. SENSATION 7FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0434
Device Problems Device Displays Incorrect Message (2591); Calibration Problem (2890)
Patient Problems Bradycardia (1751); Death (1802); Low Blood Pressure/ Hypotension (1914)
Event Date 02/07/2016
Event Type  Death  
Manufacturer Narrative
Correction: date was not entered in the initial mdr. Date: (b)(6) 2016.
 
Event Description
On (b)(6) 2016 05:47 pm (gmt-5:00) added by trackwise webservices (cpl) (tws): this was a stemi patient that after the pci procedure his heart rate and bp started dropping. Then cpr was started and they inserted the sensation 40 iab. At first the pump stated no trigger and the staff put on the ecg leads, then the pump stated optical sensor failure/ or unable to calibrate optical sensor. They continued the cpr and then they wanted to try putting the impella into the patient, but patient deceased. They did not save the catheter.
 
Manufacturer Narrative
(b)(4). The product was discarded and will not be available for an evaluation. If additional information is supplied a supplemental report will be sent. (b)(4).
 
Event Description
(b(4). This was a stemi patient that after the pci procedure his heart rate and bp started dropping. Then cpr was started and they inserted the sensation 40 iab. At first the pump stated no trigger and the staff put on the ecg leads, then the pump stated optical sensor failure/ or unable to calibrate optical sensor. They continued the cpr and then they wanted to try putting the impella into the patient, but patient deceased. They did not save the catheter.
 
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Brand NameSENSATION 7FR. 40CC IAB
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP.
14 philips parkway
montvale NJ 07645
MDR Report Key5485130
MDR Text Key106178159
Report Number2248146-2016-00023
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/30/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/07/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
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 Received02/10/2016
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

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