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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE FAIRFIELD TRANS-RAY 7FR. 34CC IAB - JAPAN SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE FAIRFIELD TRANS-RAY 7FR. 34CC IAB - JAPAN SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0513
Device Problem Unable to Obtain Readings (1516)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/01/2017
Event Type  malfunction  
Manufacturer Narrative
'report source' should have excluded distributor in previous report. Device evaluation: the product was returned with the membrane completely unfolded and blood on the exterior and interior of the catheter. The extender tubing was also returned. Dried blood was found occluding the inner lumen. The occlusion was unable to be cleared. An underwater leak test of the balloon, catheter, y-fitting and extracorporeal and extender tubing was performed and one leak was detected on the membrane approximately 1. 0cm from the rear seal measuring 0. 02cm in length. A sensor output test was performed and the sensor was found to be within specification. The evaluation could not confirm the reported difficult/unable to monitor arterial waveform problem. An evaluation of the product was unable to duplicate the reported problem. A leak 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 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. Complaint # (b)(4).
 
Event Description
It was reported that on (b)(6) /2017 intra-aortic balloon (iab) therapy started on an ami patient. On (b)(6) 2017 during removal procedure of iab catheter, arterial pressure could not be taken from optical sensor. No patient injury was reported.
 
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) therapy started on an ami patient. On (b)(6) 2017 during removal procedure of iab catheter, arterial pressure could not be taken from optical sensor. No patient injury was reported.
 
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Brand NameTRANS-RAY 7FR. 34CC IAB - JAPAN
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 Key7144953
MDR Text Key252105934
Report Number2248146-2017-00733
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 Biomedical Engineer
Type of Report Initial,Followup
Report Date 02/15/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/22/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/03/2020
Device Catalogue Number0684-00-0513
Device Lot Number3000043012
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/20/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received01/29/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/03/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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