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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 - JAPAN SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE FAIRFIELD YAMATO PLUS-R 7.5FR. 30CC IAB - JAPAN SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0549-01
Device Problems Inflation Problem (1310); Material Rupture (1546)
Patient Problem High Blood Pressure/ Hypertension (1908)
Event Date 08/30/2018
Event Type  malfunction  
Manufacturer Narrative
Distributor name: (b)(4). The device has not been returned to the manufacturer so we are unable to complete an evaluation. If provided we will send a supplemental report with our additional findings. (b)(4).
 
Event Description
It was reported that during intra-aortic balloon therapy there was an iab rupture noted. The iab was removed and therapy was discontinued. It was noted that since the iab inflation was not enough when it was inserted that the surgeon used a syringe for iab unwrapping. The patient's arterial pressure was higher than normal. But this was noted prior to the initiation of therapy. There was no patient injury reported.
 
Manufacturer Narrative
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 therapy there was an iab rupture noted. The iab was removed and therapy was discontinued. It was noted that since the iab inflation was not enough when it was inserted that the surgeon used a syringe for iab unwrapping. The patient's arterial pressure was higher than normal. But this was noted prior to the initiation of therapy. There was no patient injury reported.
 
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Brand NameYAMATO PLUS-R 7.5FR. 30CC IAB - JAPAN
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key7893581
MDR Text Key121450176
Report Number2248146-2018-00553
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
Type of Report Initial,Followup,Followup
Report Date 10/23/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/07/2019
Device Catalogue Number0684-00-0549-01
Device Lot Number3000030695
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/20/2018
Was the Report Sent to FDA?
Device Age YR
Event Location No Information
Date Manufacturer Received10/17/2018
Is This a Reprocessed and Reused Single-Use Device? No

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