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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD MEGA 7.5FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - FAIRFIELD MEGA 7.5FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0684-00-0295-02
Device Problems Leak/Splash (1354); Off-Label Use (1494)
Patient Problems Stroke/CVA (1770); Convulsion/Seizure (4406)
Event Date 08/31/2021
Event Type  Death  
Manufacturer Narrative
Occupation: respiratory therapist. 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 record id # (b)(4).
 
Event Description
It was reported that after approximately 14 days of intra-aortic balloon (iab) therapy, a change in patient mentation occurred including seizure activity and stroke alert. During transport, blood was seen in the helium line and the tubing was clamped. The insertion was reported to be right axillary, which is not the method described in the device instructions for use. The iab was removed and a new one was inserted in the left axillary.
 
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Brand NameMEGA 7.5FR. 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
brian schaeffer
15 law drive
fairfield, NJ 
MDR Report Key12515039
MDR Text Key272776076
Report Number2248146-2021-00618
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K120868
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 11/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0684-00-0295-02
Device Catalogue Number0684-00-0293
Device Lot Number3000132559
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/20/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/03/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/24/2020
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: 09/22/2021 Patient Sequence Number: 1
Treatment
AUTOCAT 2 WAVE CONSOLE
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