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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE FAIRFIELD SENSATION PLUS 8FR. 50CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE FAIRFIELD SENSATION PLUS 8FR. 50CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0575
Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Leak/Splash (1354); Device Displays Incorrect Message (2591)
Patient Problems Hemorrhage/Bleeding (1888); Rupture (2208); Cardiogenic Shock (2262)
Event Date 10/07/2017
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 a patient had an intra-aortic balloon (iab) inserted.Approximately 36 hours after insertion there was an iab rupture.An alarm 'gas gain' was generated and the console went into standby.Upon inspection by the nurse, blood was noted coming down the helium line rapidly.Helium line clamped and removed from iab pump machine.The iab was removed and the therapy was discontinued.The indication for use was cardiogenic shock.There was no reported injury to the patient.
 
Manufacturer Narrative
The product was returned with the membrane completely unfolded and blood on the interior and exterior of the catheter.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 tubing was performed and one leak was detected on the membrane approximately 1.0cm from the rear seal measuring 0.05cm in length.The reported blood in tubing & alarm, gas gain was most likely triggered by a leak which 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 a patient had an intra-aortic balloon (iab) inserted.Approximately 36 hours after insertion there was an iab rupture.An alarm 'gas gain' was generated and the console went into standby.Upon inspection by the nurse, blood was noted coming down the helium line rapidly.Helium line clamped and removed from iab pump machine.The iab was removed and the therapy was discontinued.The indication for use was cardiogenic shock.There was no reported injury to the patient.
 
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Brand Name
SENSATION PLUS 8FR. 50CC IAB
Type of Device
SYSTEM, 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 Key7262596
MDR Text Key100044787
Report Number2248146-2018-00085
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K112327
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 03/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/11/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/16/2019
Device Catalogue Number0684-00-0575
Device Lot Number3000040308
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/26/2018
Is the Reporter a Health Professional? Yes
Device AgeYR
Date Manufacturer Received02/19/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/16/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age84 YR
Patient Weight60
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