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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 Problems Device Alarm System (1012); Defective Component (2292)
Patient Problems Angina (1710); Death (1802)
Event Date 09/10/2017
Event Type  malfunction  
Manufacturer Narrative
The product was returned with the membrane completely unfolded and blood on the exterior of the catheter and between the catheter and the sheath. The returned sheath was over the catheter and partially covering the rear portion of the balloon. The pressure tubing was also returned. An underwater leak test of the balloon, catheter, y-fitting, extracorporeal and pressure tubing was performed and no leaks were detected. The iab was placed on the cs300 pump and the iab fully inflated. No alarm sounded from the pump. An evaluation of the product was unable to duplicate the reported problem. The product performed according to specification. 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
It was reported that on (b)(6) 2017 intra-aortic balloon (iab) was used on angina pectoris patient in emergency. Defective expansion of balloon occurred during procedure continuously. Iab was used continuously. No alarm was generated. Surgery was ended with no adverse event on a patient. Removed iab and discontinued therapy.
 
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. (b)(4).
 
Event Description
It was reported that on (b)(6) 2017 intra-aortic balloon (iab) was used on angina pectoris patient in emergency. Defective expansion of balloon occurred during procedure continuously. Iab was used continuously. No alarm was generated. Surgery was ended with no adverse event on a patient. Removed iab and discontinued therapy.
 
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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 Key6912544
MDR Text Key251364206
Report Number2248146-2017-00436
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,consum
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/27/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/03/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/21/2019
Device Catalogue Number0684-00-0604
Device Lot Number3000036895
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/25/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received10/23/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/07/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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