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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD YAMATO PLUS-R 7.5FR. 30CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - 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 Problems Material Deformation (2976); Pressure Problem (3012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/02/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(6).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 after approximately one day of intra-aortic balloon (iab) therapy, the console generated an alarm and the internal waveform was slightly irregular.Soon after, therapy was completed and the iab was removed.The customer noted that there was a kink mark on the tip of the catheter.There was no patient harm or adverse event 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.Reference complaint # (b)(4).
 
Event Description
It was reported that after approximately one day of intra-aortic balloon (iab) therapy, the console generated an alarm and the internal waveform was slightly irregular.Soon after, therapy was completed and the iab was removed.The customer noted that there was a kink mark on the tip of the catheter.There was no patient harm or adverse event reported.
 
Event Description
N/a.
 
Manufacturer Narrative
The product was returned with the membrane loosely folded with blood on the exterior of the catheter.The pressure tubing was also returned.A catheter tubing kink was observed near the y-fitting at approximately 71.6cm from the iab tip.An underwater leak test of the balloon, catheter tubing, y-fitting, extracorporeal tubing and pressure tubing was performed and no leaks were detected.The technician inserted a laboratory 0.018¿ guidewire through the inner lumen.No obstruction felt.The iab was placed on the cs300 pump for two hours, which represents one complete autofill cycle.The iab inflated normally, no alarm sounded.The reported pressure waveform issue cannot be confirmed by the evaluation.We were unable to duplicate the clinical settings.However, the evaluation confirmed the presence of a kink, which may have contributed to the reported event.A non-conforming material report review was completed for the reported product.No nonconformances were found that are considered to be related to the event.Analysis of production (3331/213) - the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/serial number.Based on the review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis (4109/213) - the review of the historical data was performed.Trend analysis (4110/213) - the overall complaint trend data for the period apr-19 through mar-21 was reviewed.Communication/interviews: (4111/213) communication/interviews were performed to obtain all possible information.Reference complaint # (b)(4).
 
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Brand Name
YAMATO PLUS-R 7.5FR. 30CC IAB
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ
MDR Report Key11589811
MDR Text Key243927367
Report Number2248146-2021-00202
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,foreig
Type of Report Initial,Followup,Followup
Report Date 08/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/24/2023
Device Catalogue Number0684-00-0549-01
Device Lot Number3000115414
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/19/2021
Date Manufacturer Received08/03/2021
Patient Sequence Number1
Patient Age71 YR
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