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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD YAMATO PLUS-R 7.5FR. 35CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - 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 Filling Problem (1233)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/12/2020
Event Type  malfunction  
Manufacturer Narrative
Event site postal code: (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.Complaint record id # 391888.
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy, the intra-aortic balloon pump (iabp) generated an autofill error alarm.The customer turned the iabp off and on again, but it then generated a check iab catheter alarm.The iab and iabp were both replaced.There was no patient harm or adverse event reported.A separate report will be submitted for iabp.
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy, the intra-aortic balloon pump (iabp) generated an autofill error alarm.The customer turned the iabp off and on again, but it then generated a check iab catheter alarm.The iab and iabp were both replaced.There was no patient harm or adverse event reported.A separate report will be submitted for iabp.
 
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).
 
Manufacturer Narrative
Corrected information: section d changed lot # 3000073607 to 3000072258 section d changed exp date 07/20/2021 to 04/01/2021 section h changed manufacture date 07/20/2018 to 04/02/2018 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 pressure and extender tubing were also returned.One kink was found on the catheter tubing near the y-fitting approximately 73.9cm from the iab tip.A second kink was found on the catheter tubing and inner lumen approximately 40.6cm from the iab tip.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal, pressure and extender tubing was performed and a leak was detected on the membrane at approximately 1.3cm from the rear seal and measuring approximately 0.013 cm in length.The reported problem was most likely triggered by a leak which was found on the membrane.Under magnification, a whitish patch was observed around the leak.This whitish patch is the typical appearance of an abrasion mark which is caused by calcified plaque in the aorta.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.Reference complaint # (b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy, the intra-aortic balloon pump (iabp) generated an autofill error alarm.The customer turned the iabp off and on again, but it then generated a check iab catheter alarm.The iab and iabp were both replaced.There was no patient harm or adverse event reported.A separate report will be submitted for iabp.
 
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Brand Name
YAMATO PLUS-R 7.5FR. 35CC IAB
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key10945267
MDR Text Key219497120
Report Number2248146-2020-00643
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 05/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/01/2021
Device Catalogue Number0684-00-0549-02
Device Lot Number3000072258
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/08/2021
Date Manufacturer Received05/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
CS300; CS300
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