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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION 7FR. 34CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - FAIRFIELD SENSATION 7FR. 34CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0433
Device Problems Display or Visual Feedback Problem (1184); Filling Problem (1233); Leak/Splash (1354); Material Deformation (2976); Noise, Audible (3273)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 03/25/2019
Event Type  malfunction  
Manufacturer Narrative
Complete event site name - (b)(6). Additional initial reporter - (b)(6), charge nurse & amber bedside rn. 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. (b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy on a heart failure patient, the customer had kinked the balloon and noticed an audible hiss when attempting to fill the iab. The console alarmed auto-fill failure and leak in iab circuit. There was no visible blood in the tubing. The physician was on the way in to remove the balloon as a result of their conclusion that there was a fracture in the balloon shaft at the point of the kink and hissing. Patient taken to ccl for balloon replacement. The insertion was reported to be axillary, which is not the method described in the device instructions for use. There was no reported injury to the patient.
 
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Brand NameSENSATION 7FR. 34CC IAB
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer (Section G)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer Contact
15 law drive
fairfield, NJ 07004
MDR Report Key8509243
MDR Text Key142522666
Report Number2248146-2019-00293
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/17/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/07/2021
Device Catalogue Number0684-00-0433
Device Lot Number3000085808
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/08/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device Age YR
Event Location No Information
Date Manufacturer Received05/14/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/07/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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