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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE FAIRFIELD TRANS-RAY PLUS 7.5 FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE FAIRFIELD TRANS-RAY PLUS 7.5 FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0605
Device Problem Backflow (1064)
Patient Problem Calcium Deposits/Calcification (1758)
Event Date 05/19/2018
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.Complaint # (b)(4), record # (b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy on an ami (acute myocardial infarction) patient a blood back run in the catheter tube was noted.The iab was replaced to continue therapy.Moderate sclerosis, calcification, and tortuosity were noted in the patient vessel.No patient injury was reported.
 
Manufacturer Narrative
The product was returned with the membrane completely unfolded and blood on the interior and exterior of the catheter.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and one leak was detected on the membrane approximately 11.7cm from the rear seal measuring 0.064cm 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 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.(b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy on an ami (acute myocardial infarction) patient a blood back run in the catheter tube was noted.The iab was replaced to continue therapy.Moderate sclerosis, calcification, and tortuosity were noted in the patient vessel.No patient injury was reported.
 
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Brand Name
TRANS-RAY PLUS 7.5 FR. 40CC IAB
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key7600913
MDR Text Key112035612
Report Number2248146-2018-00380
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
Report Date 07/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/14/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/28/2020
Device Catalogue Number0684-00-0605
Device Lot Number3000059179
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/15/2018
Device AgeYR
Date Manufacturer Received06/15/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age71 YR
Patient Weight102
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