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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 Unable to Obtain Readings (1516)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/06/2017
Event Type  malfunction  
Manufacturer Narrative
While it was reported that the iab optical sensor was unable to take a reading, it should be noted that this iab version does not use an optical sensor to obtain a pressure reading, so the device has been evaluated for inability to obtain a reading via standard transducer method, through the inner lumen. The product was returned with the membrane completely unfolded and blood on the exterior of the catheter. Dried blood was found occluding the inner lumen. The occlusion was able to be cleared. The technician attempted to insert a 0. 025¿ laboratory guide wire through the inner lumen of the returned iab and found that the inner lumen was occluded. The technician was able to clear the occlusion and dried blood was observed at the tip of the guide wire. The technician was able to successfully aspirate/flush the inner lumen. An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected. The evaluation confirmed the reported difficult/unable to monitor pressure problem. The condition of the iab as received indicated an occlusion. This can cause difficulty during pressure monitoring. A device and lot history record review was completed for the reported product. No non-conformances were found that are considered to be related to the event. (b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy, the iab optical sensor was unable to take (a reading) upon iab insertion and during therapy. Replaced iab to continue therapy. No patient injury was reported.
 
Manufacturer Narrative
Lot # changed from: 3000038795 to: 3000031561. Distributor name: (b)(4). 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 # (b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy, the iab optical sensor was unable to take (a reading) upon iab insertion and during therapy. Replaced iab to continue therapy. No patient injury was reported.
 
Manufacturer Narrative
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 (iab) therapy, the iab optical sensor was unable to take (a reading) upon iab insertion and during therapy. Replaced iab to continue therapy. No patient injury was reported.
 
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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
Manufacturer (Section G)
DATASCOPE FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer Contact
15 law drive
fairfield, NJ 07004
MDR Report Key7156243
MDR Text Key104868672
Report Number2248146-2017-00754
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,Followup
Report Date 04/09/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/30/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/22/2019
Device Catalogue Number0684-00-0549-02
Device Lot Number3000031561
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/06/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received03/23/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/22/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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