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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE FAIRFIELD TRANS-RAY PLUS 7.5 FR. 35CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE FAIRFIELD TRANS-RAY PLUS 7.5 FR. 35CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0604
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Calcium Deposits/Calcification (1758); No Code Available (3191)
Event Date 02/20/2018
Event Type  malfunction  
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
After intra-aortic balloon (iab) was inserted in an ami (acute myocardial infarction) patient an iab optical sensor failure occurred. Used inner lumen instead to continue therapy. Mild calcification, tortuosity and moderate sclerosis were noted in the patient vessel. The patient is in iab therapy continuously. No patient injury was reported.
 
Manufacturer Narrative
The product was returned with the membrane completely unfolded and blood on the exterior of the catheter. Two kinks were found on the catheter tubing approximately 52. 8cm and 73. 2cm from the iab tip. The optical fiber was found to be broken at the kinked location of 52. 8cm. The optical fiber was found to be broken, confirming the reported alarm. It is difficult to determine when or how a break in the fiber optic occurs. However, a kink in the catheter can cause the fiber optic to break resulting in no signal or the inability to calibrate it. 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
After intra-aortic balloon (iab) was inserted in an ami (acute myocardial infarction) patient an iab optical sensor failure occurred. Used inner lumen instead to continue therapy. Mild calcification, tortuosity and moderate sclerosis were noted in the patient vessel. The patient is in iab therapy continuously. No patient injury was reported.
 
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Brand NameTRANS-RAY PLUS 7.5 FR. 35CC 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 Key7356502
MDR Text Key103287960
Report Number2248146-2018-00183
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
Type of Report Initial,Followup
Report Date 04/18/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/21/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/14/2020
Device Catalogue Number0684-00-0604
Device Lot Number3000045454
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/09/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received03/26/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/14/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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