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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 Device Displays Incorrect Message (2591)
Patient Problems Calcium Deposits/Calcification (1758); Myocardial Infarction (1969)
Event Date 12/27/2017
Event Type  malfunction  
Manufacturer Narrative
Device evaluation: the product was returned with the membrane completely unfolded and blood on the interior and exterior of the catheter and between the catheter and the sheath. The returned sheath was covering more than half of the balloon membrane but it was a competitor product. The returned inner lumen within the membrane was observed to be coiled. A visual examination of the product detected the inner lumen within the membrane was completely separated within a kink approximately 9. 4cm from iab tip. An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no other leaks were detected. The evaluation confirmed the reported alarm, unknown & leak, blood in tubing problem. The break found in the inner lumen appears to have been the result of a severe kink, which eventually failed and allowed blood to leak into the membrane and catheter tubing causing the reported alarm, unknown and blood in tubing problems. It is difficult to determine when the break occurred but it is possibly a result of patient movement during the procedure. 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 on 26/dec/2017, intra-aortic balloon (iab) therapy was initiated on an acute myocardial infarction (ami) patient. On (b)(6) 2017 in intensive care unit (icu) blood back run was noted. There was an alarm generated, but was unspecified by the customer. Moderate tortuosity and calcification were noted in the patient vessel. Replaced iab to continue iab therapy. No patient injury was reported.
 
Manufacturer Narrative
(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. (b)(4).
 
Event Description
It was reported that on 26/dec/2017, intra-aortic balloon (iab) therapy was initiated on an acute myocardial infarction (ami) patient. On (b)(6) 2017 in icu blood back run was noted. There was an alarm generated, but was unspecified by the customer. Moderate tortuosity and calcification were noted in the patient vessel. Replaced iab to continue iab 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 on (b)(6) 2017, intra-aortic balloon (iab) therapy was initiated on an acute myocardial infarction (ami) patient. On (b)(6) 2017 in icu blood back run was noted. There was an alarm generated, but was unspecified by the customer. Moderate tortuosity and calcification were noted in the patient vessel. Replaced iab to continue iab therapy. No patient injury was reported.
 
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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 Key7211853
MDR Text Key253830532
Report Number2248146-2018-00041
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 Biomedical Engineer
Type of Report Initial,Followup,Followup
Report Date 03/16/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/23/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/27/2020
Device Catalogue Number0684-00-0549-01
Device Lot Number3000054412
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/09/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received02/26/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/27/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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