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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE FAIRFIELD YAMATO PLUS-R 7.5FR. 30CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE FAIRFIELD YAMATO PLUS-R 7.5FR. 30CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0549-01
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Hemorrhage/Bleeding (1888); Aortic Dissection (2491)
Event Date 12/12/2017
Event Type  Death  
Manufacturer Narrative
Distributor should have been omitted as a report source on original mdr. Updated to reflect adverse event only as there was no reported malfunction.
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy on a patient with triple vessel disease that the patient expired during procedure. The cause of death was due to bleeding by aorta dissection. Mild tortuosity and calcification were noted in the patient vessel. Product was discarded. There was no reported malfunction of the device.
 
Manufacturer Narrative
The device was not returned and could not be evaluated. It was discarded by the user. We are unable to confirm the reported event. If new information becomes available, a supplemental report will be submitted. Complaint # (b)(4); record # (b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy on a patient with triple vessel disease that the patient expired during procedure. The cause of death was due to bleeding by aorta dissection. Mild tortuosity and calcification were noted in the patient vessel. Product was discarded.
 
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Brand NameYAMATO PLUS-R 7.5FR. 30CC 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 Key7188759
MDR Text Key105942603
Report Number2248146-2018-00023
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/14/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/01/2020
Device Catalogue Number0684-00-0549-01
Device Lot Number3000053158
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 Received02/25/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/01/2017
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: 01/14/2018 Patient Sequence Number: 1
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