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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE FAIRFIELD YAMATO PLUS-R 7.5FR. 35CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE FAIRFIELD YAMATO PLUS-R 7.5FR. 35CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0549-02
Device Problem Insufficient Information (3190)
Patient Problems Hemorrhage/Bleeding (1888); Aortic Dissection (2491)
Event Date 09/25/2016
Event Type  Injury  
Manufacturer Narrative
Date was inadvertently not entered in the initial mdr. Date: (b)(6) 2016.
 
Event Description
The iab catheter was inserted in a patient with ami, the surgeon was unable to pass through the sheath and pushed hardercausing aortal dissection. Compression applied for 90 minutes which stopped the bleeding. Intra-aortic balloon therapy was discontinued.
 
Manufacturer Narrative
The customer indicated that the device is not returning to the manufacturer and we're unable to complete an evaluation on the affected product. If additional information is provided or the product becomes available a supplemental report with our additional findings will be provided. (b)(4).
 
Event Description
The iab catheter was inserted in a patient with ami, the surgeon was unable to pass through the sheath and pushed harder causing aortal dissection. Compression applied for 90 minutes which stopped the bleeding. Intra-aortic balloon therapy was discontinued.
 
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Brand NameYAMATO PLUS-R 7.5FR. 35CC IAB
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key6052380
MDR Text Key265574482
Report Number2248146-2016-00086
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,consum
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/24/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/11/2019
Device Catalogue Number0684-00-0549-02
Device Lot Number3000023550
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received09/29/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/11/2016
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: 10/24/2016 Patient Sequence Number: 1
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