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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 7.5FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 7.5FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0567
Device Problems Failure to Advance (2524); Difficult to Advance (2920)
Patient Problem Death (1802)
Event Date 03/21/2019
Event Type  malfunction  
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 during initial start up of intra-aortic balloon (iab) therapy, the customer emergently tried to insert an iab catheter on the or table and it would not advance through the sheath. The patient subsequently expired; however, the death is not attributed to the device.
 
Event Description
It was reported that during initial start up of intra-aortic balloon (iab) therapy, the customer emergently tried to insert an iab catheter on the or table and it would not advance through the sheath. The patient subsequently expired; however, the death is not attributed to the device.
 
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 membrane and partially covering the distal end of the catheter. A laboratory insertion test was unable to be performed due to the membrane being unfurled. An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected. A leak may impact the ability to maintain vacuum. We are unable to confirm the reported difficulty during insertion because of the returned condition of the catheter and we are unable to mimic the clinical setting. 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).
 
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Brand NameSENSATION PLUS 7.5FR. 40CC IAB
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key8518197
MDR Text Key142056790
Report Number2248146-2019-00296
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K122628
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 05/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/16/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2021
Device Catalogue Number0684-00-0567
Device Lot Number3000073441
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/10/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/14/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 04/16/2019 Patient Sequence Number: 1
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