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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 Kinked (1339); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/08/2018
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 there was a "check iab catheter" alarm generated during intra-aortic balloon (iab) therapy on a patient.The iab was in place for 3 days without issue.The customer attempted several troubleshooting techniques to locate a possible kink or restriction.The customer stated the iab indicator would show one inflation cycle and the ap (arterial pressure) waveform would show one diastolic augmentation every time he attempted to do an iab fill and started the iab pump.The customer thought the iab membrane was compromised.No blood was visualized in the helium tubing during troubleshooting or the iab fill process.Several troubleshooting techniques were repeated with no success.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 and between the catheter and the sheath.The returned sheath was over the catheter.The extender tubing was also returned.One kink was found on the catheter tubing approximately 54.9cm from the iab tip.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal and extender tubing was performed and one leak was detected on the membrane approximately 2.0cm from the rear seal measuring 0.01m in length.The optical fiber was found to be broken within the membrane at 25.1cm from iab tip.The optical fiber was found to be broken, confirming the reported monitor balloon waveform problem.We are unable to determine when this may have occurred.The additional reported alarm, check iab catheter problem was most likely triggered by a kink on the catheter or 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.(b)(4).
 
Event Description
It was reported that there was a "check iab catheter" alarm generated during intra-aortic balloon (iab) therapy on a patient.The iab was in place for 3 days without issue.The customer attempted several troubleshooting techniques to locate a possible kink or restriction.The customer stated the iab indicator would show one inflation cycle and the ap (arterial pressure) waveform would show one diastolic augmentation every time he attempted to do an iab fill and started the iab pump.The customer thought the iab membrane was compromised.No blood was visualized in the helium tubing during troubleshooting or the iab fill process.Several troubleshooting techniques were repeated with no success.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 Key7477208
MDR Text Key107214630
Report Number2248146-2018-00299
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112327
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 05/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/01/2020
Device Catalogue Number0684-00-0575
Device Lot Number3000063811
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/17/2018
Is the Reporter a Health Professional? Yes
Device AgeYR
Initial Date Manufacturer Received 04/08/2018
Initial Date FDA Received05/01/2018
Supplement Dates Manufacturer Received05/04/2018
Supplement Dates FDA Received05/24/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2017
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 Age58 YR
Patient Weight79
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