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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 Problem Backflow (1064)
Patient Problems Calcium Deposits/Calcification (1758); Heart Failure (2206); No Code Available (3191)
Event Date 10/19/2018
Event Type  Injury  
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 an intra-aortic balloon (iab) was inserted into a cardiac failure patient.And a blood back run was noted in the catheter tubing upon initiation of therapy.The iab was replaced in the opposite leg to continue therapy.The patient required an additional incision to insert the iab catheter.Mild tortuosity and sclerosis, and severe calcification were noted in the patient vessel.
 
Manufacturer Narrative
A device and lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.Complaint # (b)(4), record # (b)(4).
 
Event Description
It was reported that an intra-aortic balloon (iab) was inserted into a cardiac failure patient.And a blood back run was noted in the catheter tubing upon initiation of therapy.The iab was replaced in the opposite leg to continue therapy.The patient required an additional incision to insert the iab catheter.Mild tortuosity and sclerosis, and severe calcification were noted in the patient vessel.
 
Event Description
It was reported that an intra-aortic balloon (iab) was inserted into a cardiac failure patient.And a blood back run was noted in the catheter tubing upon initiation of therapy.The iab was replaced in the opposite leg to continue therapy.The patient required an additional incision to insert the iab catheter.Mild tortuosity and sclerosis, and severe calcification were noted in the patient vessel.
 
Manufacturer Narrative
The product was returned with the membrane completely unfolded and traces of blood on the exterior of the catheter.The catheter tubing was observed to be flattened along its length.This may occur if a vacuum is held with the one-way valve attached for a long period of time on the catheter causing the catheter tubing to lose its round shape.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and one leak was detected on the membrane approximately 17.5cm from the rear seal measuring 0.013cm in length.The reported problem was most likely triggered by a leak which was found on the membrane.The penetration found on the membrane appears to have been caused by a sharp object.The evaluation confirmed the reported problem.We are unable to determine when this may have occurred.A lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.Complaint # (b)(4).
 
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Brand Name
YAMATO PLUS-R 7.5FR. 30CC IAB - JAPAN
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key8070611
MDR Text Key127133165
Report Number2248146-2018-00655
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 01/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/14/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/12/2018
Device Catalogue Number0684-00-0549-01
Device Lot Number3000019030
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/10/2018
Device Age YR
Date Manufacturer Received01/11/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age75 YR
Patient Weight47
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